510(k) · Cleared
ClearedSkin Clear SRVH Long-Pulsed ND: Yag Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Global USA Distribution, LLC · GEX Powered Laser Surgical Instrument
Cleared on Apr 7, 2008 as substantially equivalent to K032459 (Sciton, Inc, 2004) and 5 other predicates after a 26-day review. Its family tree reaches back 14 generations to 1995.
- Decided
- Apr 7, 2008
- Review
- 26 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K943450 (1995). 335 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- 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 deviceK080697 Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC · 2008
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 deviceK080697 Skin Clear SRVH Long-Pulsed ND: Yag LaserGlobal USA Distribution, LLC · 2008
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) | K080697 | Skin Clear SRVH Long-Pulsed ND: Yag Laser | Global USA Distribution, LLC | 2008 | — |
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 | 23 | 0 |
| 1997 | 26 | 0 |
| 1998 | 23 | 0 |
| 1999 | 20 | 0 |
| 2000 | 29 | 0 |
| 2001 | 30 | 0 |
| 2002 | 36 | 0 |
| 2003 | 32 | 0 |
| 2004 | 16 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 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? (6)
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 |
|---|---|---|---|
| * | K032459 | Profile 1320 Laser SystemSummary page 1…ication Name: Instrument, Powered, Laser 79-GEX 21 CFR 878.4810 Legally Marketed Predicate Sciton Profile ThermaScan (K032459), Devices: CoolTouch CT3S Nd: YAG Laser System (K043046), Cutera CoolGli… | 2004 |
| * | K043046 | Cooltouch, Model CT3SSummary page 1…ally Marketed Predicate Sciton Profile ThermaScan (K032459), Devices: CoolTouch CT3S Nd: YAG Laser System (K043046), Cutera CoolGlide CV Laser (K023954), Cynosure Acclaim Dermatology… | 2005 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…ices: CoolTouch CT3S Nd: YAG Laser System (K043046), Cutera CoolGlide CV Laser (K023954), Cynosure Acclaim Dermatology Laser (K011828), Sciton Profile Multi-Platform… | 2003 |
| * | K011828 | Cynosure Acclaim Dermatology LaserSummary page 1…(K043046), Cutera CoolGlide CV Laser (K023954), Cynosure Acclaim Dermatology Laser (K011828), Sciton Profile Multi-Platform System (K070388), Candela GentleYag… | 2001 |
| * | K070388 | Profile Multi-Platform SystemSummary page 1…(K023954), Cynosure Acclaim Dermatology Laser (K011828), Sciton Profile Multi-Platform System (K070388), Candela GentleYag (K033172) 7-1 Description… | 2007 |
| * | K033172 | Candela Gentleyag Family of Laser SystemsSummary page 1…Laser (K011828), Sciton Profile Multi-Platform System (K070388), Candela GentleYag (K033172) 7-1 Description of the Long-Pulse Nd:YAG Laser: The SKIN CLEAR SRVH Long Pul… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 10 months on median.
- 18 of the 335 ancestors have a recall of any class.
- 2 other devices also cite its predicate K032459.
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?
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos…
Read the full statement (191 words)
1064 nm: Intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins, spider veins and poikiloderma of civatte; and the treatment of benign cutaneous lesions such as warts, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos, solar lentigos, Caf6 au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the 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 of pseudofolliculitis barbae. Indicated for use on all skin types (Fitzpatrick I-IV), including tanned skin.
1320 nm: For use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue. For use in the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080697 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080697: Skin Clear SRVH Long-Pulsed ND: Yag Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080697
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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