# K101601: Affirm DO Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Sep 23, 2010 after 107 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 YAG MIR Family Laser: named in the summary without a submission number

## Indications for use
The Affirm DO Diode laser device is indicated for use in general surgery and dermatology for the coagulation of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles, and pigmented lesions.

Source page: https://510kreport.com/device/K101601
Methodology: https://510kreport.com/methodology