The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Family Of Coolglide Aesthetic Lasers.
| Device ID | K132185 |
| 510k Number | K132185 |
| Device Name: | FAMILY OF COOLGLIDE AESTHETIC LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Contact | Sandra Hansen |
| Correspondent | Sandra Hansen CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-15 |
| Decision Date | 2013-12-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722022318 | K132185 | 000 |
| 00816722022349 | K132185 | 000 |
| 00816722021311 | K132185 | 000 |
| 00816722022325 | K132185 | 000 |
| 00816722022356 | K132185 | 000 |
| 08167222022349 | K132185 | 000 |
| 00816722021304 | K132185 | 000 |
| 00816722021502 | K132185 | 000 |
| 00816722022301 | K132185 | 000 |
| 00816722022363 | K132185 | 000 |