# K965128: Cynosure Photogenica VLV Cutaneous Vascular Lesion Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Jul 14, 1997 after 203 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The PhotoGenica VLV laser is used for the treatment of benign cutaneous vascular and vascular dependent lesions.

Source page: https://510kreport.com/device/K965128
Methodology: https://510kreport.com/methodology