510(k) · Cleared
ClearedJoule Multi-Platform System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 1 generation backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- This deviceK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · cites it directly · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 2 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 3 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- Descendant · 2 generations on · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 1 generation backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- This deviceK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Showing 5 of 111 descendants. See all descendants
Descendants cleared per year
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −1 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| 0 (this device) | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +1 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +2 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +3 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| +2 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 30 | 0 |
| 1999 | 25 | 0 |
| 2000 | 34 | 0 |
| 2001 | 32 | 0 |
| 2002 | 40 | 0 |
| 2003 | 46 | 0 |
| 2004 | 32 | 0 |
| 2005 | 25 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 16 | 0 |
| 2009 | 5 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 3 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 18 | 0 |
| 2023 | 9 | 0 |
| 2024 | 13 | 0 |
| 2025 | 14 | 0 |
| 2026 | 11 | 0 |
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 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081352 | Profile Multi-Platform SystemSummary 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… | 2008 |
| * | K081324 | Candela Family of Q-Switched Alexandrite LasersSummary 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… | 2008 |
| * | K072868 | Accolade II LaserSummary 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… | 2007 |
| * | K070388 | Profile Multi-Platform SystemSummary 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… | 2007 |
| * | K060033 | Profile Multi-Platform SystemSummary 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… | 2006 |
| * | K023881 | Profile 1064 Laser SystemSummary 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… | 2003 |
| * | K083899 | Revlite Q-Switched ND:Yag Laser SystemSummary 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:… | 2009 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary 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… | 2008 |
| * | K050382 | Affinity QS Q-Switched ND:Yag Laser SystemSummary 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:… | 2005 |
| * | K083613 | Quanta System Polysurge Diode Laser FamilySummary 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… | 2008 |
| * | K082230 | Vectra Plus Laser System and AccessoriesSummary 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… | 2010 |
| * | K082225 | 15W Ceralas D 1470NM Diode Laser, Model D1470Summary 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:… | 2008 |
| * | K101506 | LUX1540, 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… | 2010 |
| * | K090195 | Palomar LUX1540 HandpieceSummary 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… | 2009 |
| * | K070284 | Fralex 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)… | 2007 |
| * | K100270 | Artisan Aesthetic SystemSummary 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… | 2010 |
| * | K042165 | Cutera Tabletop Aesthetic ProductSummary 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… | 2004 |
| * | K042630 | Revlight Skin Care SystemSummary 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… | 2005 |
What descends from it? (111)
See all 1116 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesGEX 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
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
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.
https://510kreport.com/device/K101916 · printed Nov 6, 2026
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