# K994427: Cynosure M2 Dermatology Laser for Hair Removal

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Jan 18, 2000 after 19 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) Cynosure Apogee Laser: named in the summary without a submission number

## Indications for use
The M2 Laser is indicated for hair removal and benign vascular lesion removal applications.

Source page: https://510kreport.com/device/K994427
Methodology: https://510kreport.com/methodology