# K080697: Skin Clear SRVH Long-Pulsed ND: Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Global USA Distribution, LLC
- Decided: Apr 7, 2008 after 26 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 335 ancestors in all.
No later device cites it as a predicate yet.
0 of 336 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032459: Profile 1320 Laser System, Sciton, Inc (2004) Summary page 1.
- K043046: Cooltouch, Model CT3S, New Star Lasers, Inc. (2005) Summary page 1.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K011828: Cynosure Acclaim Dermatology Laser, Cynosure, Inc. (2001) Summary page 1.
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K080697
Methodology: https://510kreport.com/methodology