# K011828: Cynosure Acclaim Dermatology Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 7, 2001 after 87 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 PhotoGenica DL Laser: named in the summary without a submission number
- (no number) Altus Medical Aesthetic Nd:YAG Laser: named in the summary without a submission number

## Most influential descendants
- K080697: Skin Clear SRVH Long-Pulsed ND: Yag Laser (2008), 0 descendants of its own

## Indications for use
The Cynosure Acclaim Dermatology Laser is indicated for the treatment of benign cutaneous vascular lesions and hair removal.

Source page: https://510kreport.com/device/K011828
Methodology: https://510kreport.com/methodology