# K971737: Cynosure Photogenica Lpir Dermatological Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Aug 8, 1997 after 88 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.
1,000 later devices descend from it; 8 cite it directly.
0 of 1,001 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K981351: Candela Gentlelase GL Dermatological Laser (1998), 811 descendants of its own
- K991798: Acme Medical Aesthetic ND:Yag Laser (2000), 745 descendants of its own
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K993671: Candela Sclero Long Pulse Dye Laser (2000), 700 descendants of its own
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 descendants of its own

## Indications for use
The PhotoGenica LPIR laser is indicated for hair reduction.

Source page: https://510kreport.com/device/K971737
Methodology: https://510kreport.com/methodology