# K111350: Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System

- Pathway: 510(k) (Traditional)
- Applicant: Medicam, Inc.
- Decided: Sep 29, 2011 after 139 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 8 generations back to K910422 (1992). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.

## Indications for use
The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: >Removal of unwanted hair from all skin types (640nm to 1200nm); >Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm); > Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and > Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm). The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: > Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and > Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm). The devices are intended for prescription use. The device is intended for prescription use.

Source page: https://510kreport.com/device/K111350
Methodology: https://510kreport.com/methodology