510(k) Report

510(k) · Cleared

Cleared

Joule Multi-Platform System

K101916510(k) TraditionalCleared Mar 18, 2011252-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sciton, Inc · GEX Powered Laser Surgical Instrument

Cleared on Mar 18, 2011 as substantially equivalent to K081352 (Sciton, Inc, 2008) and 17 other predicates after a 252-day review. Its family tree reaches back 18 generations to 1995. 111 later devices descend from it.

Decided
Mar 18, 2011
Review
252 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
18

Its longest line of descent runs back 18 generations to K943450 (1995). 496 ancestors in all, the oldest K771218 (1978). 111 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 2 other ancestors2009: 5 other ancestors2008: 16 other ancestors2007: 16 other ancestors2006: 15 other ancestors2005: 25 other ancestors2004: 32 other ancestors2003: 46 other ancestors2002: 40 other ancestors2001: 32 other ancestors2000: 34 other ancestors1999: 25 other ancestors1998: 30 other ancestors1997: 31 other ancestors1995: 25 other ancestors1994: 25 other ancestors1993: 12 other ancestors1991: 8 other ancestors1990: 7 other ancestors1996: 30 other ancestors1992: 5 other ancestors1988: 4 other ancestors1982: 2 other ancestors1989: 4 other ancestors1986: 1 other ancestor1981: 1 other ancestor1978: 1 other ancestor1987: 2 other ancestors1980: 1 other ancestor1985: 1 other ancestor2014: 3 descendants cleared2018: 8 descendants cleared2022: 18 descendants cleared2020: 11 descendants cleared2017: 4 descendants cleared2015: 5 descendants cleared2025: 14 descendants cleared2019: 6 descendants cleared2024: 13 descendants cleared2023: 9 descendants cleared2021: 8 descendants cleared2016: 1 descendant cleared2026: 11 descendants clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006×2: 2 generations cleared close together, K071295 (2007), K072106 (2007) K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 2009K082230 · Vectra Plus Laser System and Accessories · Xintec Corporation · 201019801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 114 other ancestors3 generations back: 167 other ancestors4 generations back: 112 other ancestors5 generations back: 54 other ancestors6 generations back: 13 other ancestors7 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 20 descendants3 generations forward: 30 descendants4 generations forward: 34 descendants5 generations forward: 18 descendants6 generations forward: 3 descendants K082230 · Vectra Plus Laser System and Accessories · Xintec Corporation · 2010K083682 · 180W Cerelas D 980NM Diode Laser, Model D180 · Biolitec, Inc. · 2009K072106 · 150W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K071295 · 100W Ceralas D 980NM Diode Laser · Biolitec, Inc. · 2007K053540 · Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are Used with Them to Deliver Laser Ene · Intermedic Arfran, SA · 2006K041959 · Polaris DS/Comet · Syneron Medical, Ltd. · 2004K031671 · Polaris WR · Syneron Medical, Ltd. · 2003K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50+5
  1. Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 14 generations between
  3. 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  4. 2 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  5. 1 generation backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  6. This deviceK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  7. Descendant · cites it directly · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  8. Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  9. Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
  10. Descendant · 3 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
  11. Descendant · 2 generations on · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
Show all 18 generations
  1. Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
  14. 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
  15. 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  16. 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
  17. 2 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
  18. 1 generation backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
  19. This deviceK101916 Joule Multi-Platform SystemSciton, Inc · 2011

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

2014: 32015: 52016: 12017: 42018: 82019: 62020: 112021: 82022: 182023: 92024: 132025: 142026: 11
2014high 18 (2022) · low 1 (2016)2026

Most influential descendants

Showing 5 of 111 · See all
  • K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · cites it directly70descendants
  • K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 2 generations on62descendants
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · cites it directly57descendants
  • K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 3 generations on32descendants
  • K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · 2 generations on32descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−18K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−17K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−16K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−15K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−14K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−13K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−12K000944Thermage Thermacool SystemThermage, Inc.2000—
−11K013034Modification to: Thermacool IiaThermage, Inc.2001—
−10K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−9K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−8K030142Thermacool TC SystemThermage, Inc.2003—
−7K031671Polaris WRSyneron Medical, Ltd.2003—
−6K041959Polaris DS/CometSyneron Medical, Ltd.2004—
−5K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories…Intermedic Arfran, SA2006—
−4K071295100W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−3K072106150W Ceralas D 980NM Diode LaserBiolitec, Inc.2007—
−2K083682180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc.2009—
−1K082230Vectra Plus Laser System and AccessoriesXintec Corporation2010—
0 (this device)K101916Joule Multi-Platform SystemSciton, Inc2011—
+1K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
+2K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—
+1K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—
+3K153671Family of CoolGlide Aesthetic LasersCutera, Inc.2016—
+2K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198220
198510
198610
198720
198840
198940
199070
199180
199250
1993120
1994250
1995250
1996300
1997310
1998300
1999250
2000340
2001320
2002400
2003460
2004320
2005250
2006150
2007160
2008160
200950
201020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201430
201550
201610
201740
201880
201960
2020110
202180
2022180
202390
2024130
2025140
2026110
FIG. 1 — Lineage of K101916, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

  1. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (18)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K081352Profile Multi-Platform System
Summary page 1
…d Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CIFR 878.4810. Legally Marketed 755 nm Laser System Predicate Device: K081 352: Profile Multi -platform System 0-Switched 755 nm Alex K081324: Candela Family of 0…
Sciton, Inc2008—
*K081324Candela Family of Q-Switched Alexandrite Lasers
Summary page 1
…y Marketed 755 nm Laser System Predicate Device: K081 352: Profile Multi -platform System 0-Switched 755 nm Alex K081324: Candela Family of 0-Switched Alexandrite K072868: Cynosure Accolade 11Laser 1064 n…
Candela Corp.2008—
*K072868Accolade II Laser
Summary page 1
…file Multi -platform System 0-Switched 755 nm Alex K081324: Candela Family of 0-Switched Alexandrite K072868: Cynosure Accolade 11Laser 1064 nm Laser System K070388: Profile Multi-Platform Sys…
Cynosure, Inc.2007—
*K070388Profile Multi-Platform System
Summary page 1
…24: Candela Family of 0-Switched Alexandrite K072868: Cynosure Accolade 11Laser 1064 nm Laser System K070388: Profile Multi-Platform System K060033: Profile Multi-Platform System K023881: Prof…
Sciton, Inc2007—
*K060033Profile Multi-Platform System
Summary page 1
…K072868: Cynosure Accolade 11Laser 1064 nm Laser System K070388: Profile Multi-Platform System K060033: Profile Multi-Platform System K023881: Profile 1064 Laser System 0-Switched 106415…
Sciton, Inc2006—
*K023881Profile 1064 Laser System
Summary page 1
…1064 nm Laser System K070388: Profile Multi-Platform System K060033: Profile Multi-Platform System K023881: Profile 1064 Laser System 0-Switched 10641532 nm Nd:YAG K083899: Hoya ConBio RevLi…
Sciton, Inc2003—
*K083899Revlite Q-Switched ND:Yag Laser System
Summary page 1
…0033: Profile Multi-Platform System K023881: Profile 1064 Laser System 0-Switched 10641532 nm Nd:YAG K083899: Hoya ConBio RevLite 0-Switched Nd:YAG Laser System K072564: Alma Harmony XL Multi-Platform 0-Switched Nd:…
Hoya Conbio, Inc.2009—
*K072564Alma Lasers Harmony XL Multi-Application Platform
Summary page 1
…ser System 0-Switched 10641532 nm Nd:YAG K083899: Hoya ConBio RevLite 0-Switched Nd:YAG Laser System K072564: Alma Harmony XL Multi-Platform 0-Switched Nd:YAG K050382: Cynosure Affinity OS 0-Switched Nd:YAG Laser Sy…
Alma Lasers, Ltd.2008—
*K050382Affinity QS Q-Switched ND:Yag Laser System
Summary page 1
…K083899: Hoya ConBio RevLite 0-Switched Nd:YAG Laser System K072564: Alma Harmony XL Multi-Platform 0-Switched Nd:YAG K050382: Cynosure Affinity OS 0-Switched Nd:YAG Laser System 1319 nm Laser System K081352:…
Cynosure, Inc.2005—
*K083613Quanta System Polysurge Diode Laser Family
Summary page 1
…on Profile Multi-Platform System K060033: Sciton Profile Multi-Platform System 1470 nmn Laser System K083613: Quanta System Polysurge Diode Laser Family K082230: Xintec Vectra Family of Laser Systems and Accessories…
Quanta System Spa2008—
*K082230Vectra Plus Laser System and Accessories
Summary page 1
…file Multi-Platform System 1470 nmn Laser System K083613: Quanta System Polysurge Diode Laser Family K082230: Xintec Vectra Family of Laser Systems and Accessories K082225: Biolitec Geralas D 1470 nm Diode Laser…
Xintec Corporation2010—
*K08222515W Ceralas D 1470NM Diode Laser, Model D1470
Summary page 1
…K083613: Quanta System Polysurge Diode Laser Family K082230: Xintec Vectra Family of Laser Systems and Accessories K082225: Biolitec Geralas D 1470 nm Diode Laser 1470 nm Laser System (Fractional) K101506:…
Biolitec, Inc.2008—
*K101506LUX1540, LUX1440 & LUX2940 Laser Handpieces
Cleared while this submission was under review
Summary page 1
…ms and Accessories K082225: Biolitec Geralas D 1470 nm Diode Laser 1470 nm Laser System (Fractional) K101506: Palomar Lux 1440 K090195: Palomar Luxl1540 K070284: Reliant Technologies Fraxel SR…
Palomar Medical Technologies, Inc.2010—
*K090195Palomar LUX1540 Handpiece
Summary page 1
…: Biolitec Geralas D 1470 nm Diode Laser 1470 nm Laser System (Fractional) K101506: Palomar Lux 1440 K090195: Palomar Luxl1540 K070284: Reliant Technologies Fraxel SR1500 Laser System 1660 nm…
Palomar Medical Technologies, Inc.2009—
*K070284Fralex SR 1500 Laser System (Fralex II SR Laser System)
Summary page 1
…1470 nm Laser System (Fractional) K101506: Palomar Lux 1440 K090195: Palomar Luxl1540 K070284: Reliant Technologies Fraxel SR1500 Laser System 1660 nm Laser System (Fractional)…
Reliant Technologies, Inc.2007—
*K100270Artisan Aesthetic System
Summary page 1
…Multi-Platform System K070388: Profile Multi-Platform System 1 060033: Profile Multi-Platform System K100270: Palomar LUX2940 BIBL System K070388: Sciton Profile Multi-Platform System…
Palomar Medical Technologies, Inc.2010—
*K042165Cutera Tabletop Aesthetic Product
Summary page 1
…L System K070388: Sciton Profile Multi-Platform System K060033: Sciton Profile Multi-Platform System K042165: Cutera Titan K042630: RevLight Skin Care System Page 1 of 4…
Cutera, Inc.20041
*K042630Revlight Skin Care System
Summary page 1
…on Profile Multi-Platform System K060033: Sciton Profile Multi-Platform System K042165: Cutera Titan K042630: RevLight Skin Care System Page 1 of 4 Description of The J…
Skincare Technology, Inc.2005—

Also cleared against K081352: 1 other device →

What descends from it? (111)

See all 111

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.201470
K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.201457
K193656SkyPulseFotona D.O.O.202011
K173285Joule SystemSciton, Inc20185
K132976AdvatxAdvalight Aps20141
K213761Joule diVa SystemSciton, Inc20220

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 25 of the 496 ancestors have a recall of any class.
  • Of its descendants, K132806 (Fotona D.D., 2014) has gone furthest, with 70 descendants of its own.
  • 1 other device also cites its predicate K081352.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles. Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems…

Read the full statement (1,027 words)

The 755 nm Alexandrite system is designed for use in:

The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.

Q-Switched 755 nm Alexandrite Indications for Use:

The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses:

Pigmented Lesions

Tattoos

The 1064 nm Nd:YAG Indications for Use:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea.

Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB).

Treatment of facial wrinkles.

The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.

Q-Switched 1064/532 nm Nd:YAG Indications for Use:

The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses:

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

1064 nm wavelength

Tattoo Removal (dark ink: blue and black)

Nevus of Ota

Removal or lightening of hair with or without adjuvant preparation

Skin Resurfacing for Acne Scars and Wrinkles

Benign Cutaneous Lesions, such as, but not limited to: striae and scars

Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

532 nm wavelength

Tattoo Removal (light ink: yellow, red, light blue, green)

Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi

Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus

Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques

Skin Resurfacing for Acne Scars and Wrinkles

Benign Cutaneous Lesions, such as, but not limited to: striae and scars

Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The 1319 nm Nd:YAG Indications for Use:

Treatment of fine lines and wrinkles.

Treatment of atrophic acne scars.

Treatment of mild to moderate inflammatory acne vulgaris.

The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.

The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.

1470 nm Indications for Use:

The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

1550 nm Indications for Use:

The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

2940 nm Indications for Use:

The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing.

Aesthetic Surgery: Skin resurfacing and treatment of wrinkles.

Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.

The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue.

BBL (300-1400nm) Indications for Use:

The JOULE Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

It is intended for use for:

Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420nm BP filter, 515nm LP filter, 560 LP filter)

The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter)

The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)

The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter)

The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter)

Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP Filter)

The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:

Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);

Reduce discomfort during and/or associated with light or laser treatment;

Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;

Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and

Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K101916: Joule Multi-Platform System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101916

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026