# K012790: Cynosure Photogenica ER

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Nov 16, 2001 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.
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) Continuum Biomedical CB Erbium / 2.94™ Er:YAG Laser: named in the summary without a submission number

## Indications for use
The PhotoGenica ER laser is used for skin resurfacing in the treatment of wrinkles and for the incision, excision ablation or vaporization of soft bodily tissues.

Source page: https://510kreport.com/device/K012790
Methodology: https://510kreport.com/methodology