510(k) Report

510(k) · Cleared

Cleared

Profile Multi-Platform System

K070388510(k) TraditionalCleared May 2, 200782-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 May 2, 2007 as substantially equivalent to K060033 (Sciton, Inc, 2006) and 18 other predicates after an 82-day review. Its family tree reaches back 13 generations to 1995. 129 later devices descend from it.

Decided
May 2, 2007
Review
82 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
19

Its longest line of descent runs back 13 generations to K943450 (1995). 333 ancestors in all, the oldest K771218 (1978). 129 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 5 other ancestors2005: 12 other ancestors2004: 16 other ancestors2003: 32 other ancestors2001: 29 other ancestors2002: 36 other ancestors2000: 29 other ancestors1999: 20 other ancestors1998: 23 other ancestors1997: 26 other ancestors1996: 23 other ancestors1994: 18 other ancestors1995: 15 other ancestors1992: 5 other ancestors1990: 2 other ancestors1993: 11 other ancestors1991: 6 other ancestors1989: 3 other ancestors1981: 1 other ancestor1978: 1 other ancestor1988: 2 other ancestors1987: 2 other ancestors1982: 1 other ancestor1980: 1 other ancestor1985: 1 other ancestor2010: 3 descendants cleared2008: 6 descendants cleared2009: 2 descendants cleared2011: 1 descendant cleared2018: 9 descendants cleared2021: 9 descendants cleared2014: 3 descendants cleared2022: 18 descendants cleared2020: 11 descendants cleared2024: 14 descendants cleared2015: 6 descendants cleared2017: 4 descendants cleared2025: 15 descendants cleared2019: 7 descendants cleared2023: 9 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. · 2003K053616 · Polaris WR, ST Applicator · Syneron Medical, Ltd. · 200619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 17 other ancestors2 generations back: 51 other ancestors3 generations back: 90 other ancestors4 generations back: 97 other ancestors5 generations back: 49 other ancestors6 generations back: 15 other ancestors7 generations back: 1 other ancestor 1 generation forward: 8 descendants2 generations forward: 9 descendants3 generations forward: 24 descendants4 generations forward: 33 descendants5 generations forward: 34 descendants6 generations forward: 18 descendants7 generations forward: 3 descendants K053616 · Polaris WR, ST Applicator · Syneron Medical, Ltd. · 2006K031671 · 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. · 1995−10−50+5
  1. Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 9 generations between
  3. 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  4. 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  5. 1 generation backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
  6. This deviceK070388 Profile Multi-Platform SystemSciton, Inc · 2007
  7. Descendant · cites it directly · 112 of its ownK081352 Profile Multi-Platform SystemSciton, Inc · 2008
  8. Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
  9. Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
  10. Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
  11. Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Show all 13 generations
  1. Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 2 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
  13. 1 generation backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
  14. This deviceK070388 Profile Multi-Platform SystemSciton, Inc · 2007

Showing 5 of 129 descendants. See all descendants

Descendants cleared per year

2008: 62009: 22010: 32011: 12014: 32015: 62016: 12017: 42018: 92019: 72020: 112021: 92022: 182023: 92024: 142025: 152026: 11
2008high 18 (2022) · low 0 (2012)2026

Most influential descendants

Showing 5 of 129 · See all
  • K081352Profile Multi-Platform SystemSciton, Inc · 2008 · cites it directly112descendants
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
  • K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
  • K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
  • K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · 2 generations on57descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−13K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−12K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−11K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−10K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−9K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−8K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−7K000944Thermage Thermacool SystemThermage, Inc.2000—
−6K013034Modification to: Thermacool IiaThermage, Inc.2001—
−5K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−4K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−3K030142Thermacool TC SystemThermage, Inc.2003—
−2K031671Polaris WRSyneron Medical, Ltd.2003—
−1K053616Polaris WR, ST ApplicatorSyneron Medical, Ltd.2006—
0 (this device)K070388Profile Multi-Platform SystemSciton, Inc2007—
+1K081352Profile Multi-Platform SystemSciton, Inc2008—
+1K101916Joule Multi-Platform SystemSciton, Inc2011—
+2K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D.2014—
+3K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D.2015—
+2K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198010
198110
198210
198510
198720
198820
198930
199020
199160
199250
1993110
1994180
1995150
1996230
1997260
1998230
1999200
2000290
2001290
2002360
2003320
2004160
2005120
200650

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200860
200920
201030
201110
201430
201560
201610
201740
201890
201970
2020110
202190
2022180
202390
2024140
2025150
2026110
FIG. 1 — Lineage of K070388, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (19)

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
*K060033Profile Multi-Platform System
Summary page 1
…n Name: Laser/Light Powered Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed K060033: Profile Multi-Platform Laser System and Accessories Predicate Device: K062321: Cynosure SmartLipo Nd:YAG Laser System…
Sciton, Inc2006—
*K062321Smartlipo ND:Yag Laser
Summary page 1
…ion Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed K060033: Profile Multi-Platform Laser System and Accessories Predicate Device: K062321: Cynosure SmartLipo Nd:YAG Laser System K062822, K051287: Vascular Solutions Vari-Lase Lasers…
Cynosure, Inc.2006—
*K062822Vari-Lase Endovenous Laser Console, Model 7500
Summary page 1
…ed K060033: Profile Multi-Platform Laser System and Accessories Predicate Device: K062321: Cynosure SmartLipo Nd:YAG Laser System K062822, K051287: Vascular Solutions Vari-Lase Lasers K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems…
Vascular Solutions, Inc.2006—
*K051287Vari-Lase Endovenous Laser Procedure Kit
Summary page 1
…K060033: Profile Multi-Platform Laser System and Accessories Predicate Device: K062321: Cynosure SmartLipo Nd:YAG Laser System K062822, K051287: Vascular Solutions Vari-Lase Lasers K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems…
Vascular Solutions, Inc.2005—
*K062210Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160
Summary page 1
…te Device: K062321: Cynosure SmartLipo Nd:YAG Laser System K062822, K051287: Vascular Solutions Vari-Lase Lasers K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems K023954: Altus Medical CoolGlide Aesthetic Lasers…
New Star Lasers, Inc.2006—
*K061618Cooltouch, Model Ctev
Summary page 1
…: K062321: Cynosure SmartLipo Nd:YAG Laser System K062822, K051287: Vascular Solutions Vari-Lase Lasers K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems K023954: Altus Medical CoolGlide Aesthetic Lasers…
New Star Lasers, Inc.2006—
*K023954Altus Medical Coolglide Laser Systems and Accessories
Summary page 1
…K062822, K051287: Vascular Solutions Vari-Lase Lasers K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System…
Altus Medical, Inc.2003—
*K003715Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch…
Summary page 1
…K062210, K061618: CoolTouch CTEV Nd:YAG Laser Systems K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems…
Cooltouch Corp.2001—
*K050673Candela Family of Pulse Dye Laser Systems
Summary page 1
…stems K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator…
Candela Corp.20052
*K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B
Summary page 1
…K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator…
Candela Corp.2005—
*K033461Candela Vbeam Pulse Dye Laser System
Summary page 1
…K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator…
Candela Corp.2004—
*K033331Candela Cbeam Pulse Dye Laser System
Summary page 1
…K023954: Altus Medical CoolGlide Aesthetic Lasers K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator K…
Candela Corp.2004—
*K053616Polaris WR, ST Applicator
Summary page 1
…K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator K0041242: Candela Smoothbeam Laser K051255:…
Syneron Medical, Ltd.2006—
*K031671Polaris WR
Summary page 1
…K003715: CoolTouch Nd:YAG Laser System K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator K0041242: Candela Smoothbeam Laser K051255: Opusmed…
Syneron Medical, Ltd.2003—
*K041242Candela Smoothbeam Laser System
Summary page 1
…K050673, K043251, K033461, K033331: Candela Pulsed Dye Laser Systems K053616, K031671: Polaris WR, ST Applicator K0041242: Candela Smoothbeam Laser K051255: Opusmed LumiPhase-R K031425: Light BioScienc…
Candela Corp.2004—
*K051255Lumiphase-R
Summary page 1
…e Laser Systems K053616, K031671: Polaris WR, ST Applicator K0041242: Candela Smoothbeam Laser K051255: Opusmed LumiPhase-R K031425: Light BioScience GentleWaves LED Photomodulation Device…
Opusmed, Inc.2005—
*K031425Gentlewaves Led Photomodulation Device
Summary page 1
…671: Polaris WR, ST Applicator K0041242: Candela Smoothbeam Laser K051255: Opusmed LumiPhase-R K031425: Light BioScience GentleWaves LED Photomodulation Device K042165: Cutera Titan Tabletop Product…
Light Bioscience, LLC2004—
*K042165Cutera Tabletop Aesthetic Product
Summary page 1
…K051255: Opusmed LumiPhase-R K031425: Light BioScience GentleWaves LED Photomodulation Device K042165: Cutera Titan Tabletop Product K042630: RevLight Skin Care System Description of The Profile…
Cutera, Inc.20041
*K042630Revlight Skin Care System
Summary page 1
…K031425: Light BioScience GentleWaves LED Photomodulation Device K042165: Cutera Titan Tabletop Product K042630: RevLight Skin Care System Description of The Profile Multi-Platform System is a modular, multi-wavelength laser/light…
Skincare Technology, Inc.2005—

Also cleared against K060033: 8 other devices →

What descends from it? (129)

See all 129

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

NumberDeviceApplicantDecidedDescendants
K081352Profile Multi-Platform SystemSciton, Inc2008112
K101916Joule Multi-Platform SystemSciton, Inc2011111
K080567Palomar Aspire Laser PlatformPalomar Medical Products, Inc.200810
K101573Accusculpt II Laser SystemLutronic Corporation20101
K093087BWF-5 Medical Laser SeriesLitecure, LLC20100
K083165Palomar Aspire Laser PlatformPalomar Medical Products, Inc.20090
K073158Sculpture 2.94 ER:Yag SystemHoya Conbio, Inc.20080
K080697Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC20080

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 12 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 18 of the 333 ancestors have a recall of any class.
  • Of its descendants, K081352 (Sciton, Inc, 2008) has gone furthest, with 112 descendants of its own.
  • 8 other devices also cite its predicate K060033.

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. 2007, 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?

1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including…

Read the full statement (426 words)

1064 nm Indications for Use:

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

Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.

The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.

Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis.

1320 nm Indications for Use:

It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris.

Profile Multi-Platform System 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.

2940 nm Indications for Use:

Skin resurfacing and treatment of wrinkles.

Pulsed Light (300-1400 nm) Indications for Use:

The Profile 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:

• The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (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; and (590nm LP filter, 640nm LP filter, 695nm 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. (800nm LP filter)

Indications for use as stated in the FDA summary.

Also cleared against K060033

8 other devices cite the same predicate.

  • K213761Joule diVa SystemSciton, Inc · 2022
  • K141975Waterlase Iplus SBiolase, Inc. · 2015
  • K122368Waterlase Iplus All Tissue LaserBiolase Technology, Inc. · 2013
  • K101916Joule Multi-Platform SystemSciton, Inc · 2011
  • K093087BWF-5 Medical Laser SeriesLitecure, LLC · 2010
  • K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008

More from Sciton, Inc

23 FDA decisions under this applicant name. See the company

  • K251077JOULE 1064nm System and AccessoriesSciton, Inc · 2025
  • K222958mJOULE RF System and AccessoriesSciton, Inc · 2024
  • K213761Joule diVa SystemSciton, Inc · 2022
  • K213350mJOULE System and AccessoriesSciton, Inc · 2022
  • K182173Joule SystemSciton, Inc · 2019

Recent decisions in GEX

The GEX category page

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  • K262628Picosecond Laser treatment system (Z180)Sanhe PERFECTLASER Technology Co., Ltd. · 2026
  • K261572Nd:YAG & Alexandrite Long Pulse Laser Therapy Instrument (LPDuo)Keyue (Hangzhou) Medical Information Technology Co., Ltd. · 2026
  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K070388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070388: Profile 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/K070388

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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