# K051442: Photosilk Plus Pulsed Light System and Laser Attachment

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: May 24, 2006 after 356 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.
59 later devices descend from it; 2 cite it directly.
0 of 60 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) StarLux Pulsed Light System: named in the summary without a submission number
- (no number) C03 Er:YAG laser: named in the summary without a submission number
- (no number) ESC Nd:YAG Accessory: named in the summary without a submission number
- (no number) Medlite C6 Q-Switched Nd:YAG laser: named in the summary without a submission number

## Most influential descendants
- K090235: Elite MPX Laser System with XPL Handpiece (2009), 38 descendants of its own
- K152012: EVO platform (2015), 37 descendants of its own
- K160368: EVO platform (2016), 36 descendants of its own
- K163222: Discovery Pico Family (2016), 30 descendants of its own
- K171945: Discovery Pico, Discovery Pico Plus (2017), 21 descendants of its own

## Indications for use
The PhotoSilk Plus Pulsed Light System is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne. The PhotoSilk Plus Pulsed Light System Laser Attachment is intended for: Er:YAG 2,940 mn - for skin resurfacing and -for the incision, excision, ablation or vaporization of soft bodily tissues. Long Pulse Nd:YAG 1,064 nm - for the treatment of vascular lesions, pigmented lesions, wrinkles and for permanent hair reduction.. 0-Switched Nd:YAG 1,064 rim - for dark tattoo removal, and the treatment of pigmented lesions.

Source page: https://510kreport.com/device/K051442
Methodology: https://510kreport.com/methodology