# K061720: Cosmelight

- Pathway: 510(k) (Traditional)
- Applicant: Penntack Enterprises, Inc.
- Decided: Jan 31, 2007 after 226 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: 10 generations back to K910422 (1992). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K040659: Mccue PLC Energist Ultra Variable Pulsed Light System, Mccue Plc (2004) Summary page 1.
- K060516: Ellipse 12PL, Model 9ESL7228, Danish Dermatologic Development A/S (2006) Summary page 1.

## Indications for use
The Cosinelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, various benign pigmented lesions and hair removal as follow: L. Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the treatment of inflammatory acne. 2. Intense Pulse Light Energy Wavelengths from 560 - 1200 mnn are indicated for the treatment of benign pigmented (epidermal and oetaneous) lesions Including warts, scars and striae. For the treatment of benign (cutaneous) vascular lesions including port wine stains, hemangiomas, faeial truncal and leg telangiectaslas, rosacea, melasmna, angiomas and spider angiormas, polkiloderma of civatte, leg veins, facial veins and venous realformations. 3. Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are Indicated for the treatment of unwanted hair (i.e., hair removal).

Source page: https://510kreport.com/device/K061720
Methodology: https://510kreport.com/methodology