# K012806: Cynosure Photogenica VL

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Nov 19, 2001 after 90 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.
666 later devices descend from it; 1 cites it directly.
0 of 667 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) NLite Laser by ICN Pharmaceuticals, Inc.: named in the summary without a submission number

## Most influential descendants
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K023881: Profile 1064 Laser System (2003), 227 descendants of its own

## Indications for use
The Cynosure PhotoGenica VL laser is indicated for use in Dermatological and Plastic Surgery applications and the treatment of periocular wrinkles.

Source page: https://510kreport.com/device/K012806
Methodology: https://510kreport.com/methodology