510(k) · Cleared
ClearedProfile 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 Oct 23, 2008 as substantially equivalent to K070388 (Sciton, Inc, 2007) and 8 other predicates after a 162-day review. Its family tree reaches back 14 generations to 1995. 112 later devices descend from it.
- Decided
- Oct 23, 2008
- Review
- 162 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 14 generations to K943450 (1995). 352 ancestors in all, the oldest K771218 (1978). 112 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 1 generation backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- This deviceK081352 Profile Multi-Platform SystemSciton, Inc · 2008
- Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- Descendant · 2 generations on · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 4 generations on · 32 of its ownK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK053616 Polaris WR, ST ApplicatorSyneron Medical, Ltd. · 2006
- 1 generation backK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- This deviceK081352 Profile Multi-Platform SystemSciton, Inc · 2008
Showing 5 of 112 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 112 · See all- 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
- K153671Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K053616 | Polaris WR, ST Applicator | Syneron Medical, Ltd. | 2006 | — |
| −1 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| 0 (this device) | K081352 | Profile Multi-Platform System | Sciton, Inc | 2008 | — |
| +1 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +2 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +3 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| +2 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +4 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 18 | 0 |
| 1995 | 15 | 0 |
| 1996 | 24 | 0 |
| 1997 | 28 | 0 |
| 1998 | 24 | 0 |
| 1999 | 23 | 0 |
| 2000 | 31 | 0 |
| 2001 | 29 | 0 |
| 2002 | 36 | 0 |
| 2003 | 34 | 0 |
| 2004 | 19 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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? (9)
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 |
|---|---|---|---|
| * | K070388 | Profile Multi-Platform SystemSummary page 1…Name: Laser/Light Powered Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CFR 878.481 0. Legally Marketed K070388: Profile Multi-Platform Laser System and Accessories Predicate Device: K070805: ULTRAWAVE II EX 1320… | 2007 |
| * | K070805 | Ultrawave II EX 1320Summary page 1…on Name: Laser Surgical Instrument, 21 CFR 878.481 0. Legally Marketed K070388: Profile Multi-Platform Laser System and Accessories Predicate Device: K070805: ULTRAWAVE II EX 1320 K042474: ARION Laser System K034030: Cynosure Apogee Elit… | 2007 |
| * | K042474 | ARIONSummary page 1…0. Legally Marketed K070388: Profile Multi-Platform Laser System and Accessories Predicate Device: K070805: ULTRAWAVE II EX 1320 K042474: ARION Laser System K034030: Cynosure Apogee Elite Laser K024371: GentleLASE Fa… | 2004 |
| * | K034030 | Apogee EliteSummary page 1…latform Laser System and Accessories Predicate Device: K070805: ULTRAWAVE II EX 1320 K042474: ARION Laser System K034030: Cynosure Apogee Elite Laser K024371: GentleLASE Family of Laser Systems K(0242… | 2004 |
| * | K024371 | Candela Gentle Lase Family of Laser SystemSummary page 1…K070805: ULTRAWAVE II EX 1320 K042474: ARION Laser System K034030: Cynosure Apogee Elite Laser K024371: GentleLASE Family of Laser Systems K(024260: GentleLASE Family of Laser Systems… | 2003 |
| * | K024260 | Candela Gentlelase Family of Laser SystemsSummary page 1…aser System K034030: Cynosure Apogee Elite Laser K024371: GentleLASE Family of Laser Systems K(024260: GentleLASE Family of Laser Systems K(080121: Cynosure Smartlipo Multiwavelength Laser… | 2003 |
| * | K080121 | Cynosure Smartlipo Multiwavlength LaserSummary page 1…ser K024371: GentleLASE Family of Laser Systems K(024260: GentleLASE Family of Laser Systems K(080121: Cynosure Smartlipo Multiwavelength Laser K(072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser… | 2008 |
| * | K072751 | Cooltouch Models NS 160 and LC215 CoolipoSummary page 1…K(024260: GentleLASE Family of Laser Systems K(080121: Cynosure Smartlipo Multiwavelength Laser K(072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser K(072779: Ceralas D 980nm Diode Laser System (Models D1i… | 2008 |
| * | K072779 | Ceralas D 980NM Diode Laser, Models D15 and D25Summary page 1…K(080121: Cynosure Smartlipo Multiwavelength Laser K(072751: CoolTouch NS160 CoolLipo Nd:YAG Surgical Laser K(072779: Ceralas D 980nm Diode Laser System (Models D1iS, D25) Description of The Profile Multi-Platform System is a modular,… | 2008 |
What descends from it? (112)
See all 1122 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 13 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 21 of the 352 ancestors have a recall of any class.
- Of its descendants, K101916 (Sciton, Inc, 2011) has gone furthest, with 111 descendants of its own.
- 7 other devices also cite its predicate K070388.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
755 nm Indications for Use: The 755 nm Profile Multi-Platform 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. 1320 nm Indications for Use: The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision…
Read the full statement (143 words)
755 nm Indications for Use: The 755 nm Profile Multi-Platform 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.
1320 nm Indications for Use: The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis.
2940 nm Indications for Use: The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081352 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081352: Profile Multi-Platform System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081352
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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