# K031258: Cynosure Photolight PL

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jul 8, 2003 after 78 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.
20 later devices descend from it; 1 cites it directly.
0 of 21 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) EsteLux pulsed light system: named in the summary without a submission number

## Most influential descendants
- K082040: Minisilk FT (2009), 19 descendants of its own
- K103288: Deka Synchro FT (2011), 18 descendants of its own
- K131095: Deka Synchro Repla: Y Family of Laser Systems (2013), 17 descendants of its own
- K150516: Deka Synchro Repla:Y Family of Laser Systems (2015), 16 descendants of its own
- K192539: Deka Luxea (2019), 4 descendants of its own

## Indications for use
The Photolight Pulsed Light device 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 CoolHand cooling device is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain and discomfort associated with light applications.

Source page: https://510kreport.com/device/K031258
Methodology: https://510kreport.com/methodology