# K041095: Photosilk Pulsed Light System

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: May 26, 2004 after 29 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Photolight PL system: named in the summary without a submission number

## Most influential descendants
- K051508: Med Flash II Intense Pulsed Light System. (2005), 8 descendants of its own
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own

## Indications for use
The Photosilk and Photosilk Plus pulsed light system is indicated for permanent hair reduction. It is also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and the treatment of benign pigmented lesions. The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to redace patient pain and discomfort associated with light applications

Source page: https://510kreport.com/device/K041095
Methodology: https://510kreport.com/methodology