# K090618: Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo C

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Apr 14, 2009 after 36 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
Longest line of descent: 9 generations back to K963094 (1996). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040727: CRYO 5, Zimmer Elektromedizin GmbH (2004) Summary page 1.
- K060395: Cryo, Model V6.0, Zimmer Elektromedizin GmbH (2006) Summary page 1.
- K080735: Cryomini, Zimmer Elektromedizin GmbH (2008) Summary page 1.

## Indications for use
The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.

Source page: https://510kreport.com/device/K090618
Methodology: https://510kreport.com/methodology