# K032539: Cynosure Photogenica SV Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Nov 17, 2003 after 91 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. The FDA summary names its predicate without a number.
- (no number) PhotoGenica V: named in the summary without a submission number

## Indications for use
The PhotoGenica sV laser is indicated for vascular and vascular dependent lesions of the upper airway including, but not limited to, glottal dysplasia, expistaxis, laryngeal papillomas and haemorrhagic telangiectasia.

Source page: https://510kreport.com/device/K032539
Methodology: https://510kreport.com/methodology