# K973498: Cynosure Photogenica ER Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Nov 13, 1997 after 59 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 7 2.94™ Er:YAG Laser: named in the summary without a submission number

## Indications for use
The PhotoGicnica Er laser is used for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology. plastic surgery. urology, gastroenterology, neurosurgery, gynecology, arthroscopy. general surgery, ENT and ophthalmology.

Source page: https://510kreport.com/device/K973498
Methodology: https://510kreport.com/methodology