The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Enlighten Iii Laser System.
| Device ID | K160488 |
| 510k Number | K160488 |
| Device Name: | Cutera Enlighten III Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Contact | Bradley Renton |
| Correspondent | Bradley Renton 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 | 2016-02-22 |
| Decision Date | 2016-10-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722021649 | K160488 | 000 |