# K972002: Cynosure Dermatology Laser Cooling Tip

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Aug 27, 1997 after 89 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser (2002), 0 descendants of its own

## Indications for use
The Cynosure Dermatology Laser Cooling Tip is indicated for cooling the skin during dermatology laser treatment procedures.

Source page: https://510kreport.com/device/K972002
Methodology: https://510kreport.com/methodology