The following data is part of a premarket notification filed by Cynosure, Inc. with the FDA for Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 And Cryo C.
| Device ID | K090618 |
| 510k Number | K090618 |
| Device Name: | CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Contact | George Cho |
| Correspondent | George Cho CYNOSURE, INC. 5 CARLISLE ROAD Westford, MA 01886 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04053815044642 | K090618 | 000 |