The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Aviclear Laser System.
| Device ID | K213461 |
| 510k Number | K213461 |
| Device Name: | AviClear Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Cutera, Inc. 3240 Bayshore Blvd. Brisbane, CA 94005 |
| Contact | Amogh Kothare |
| Correspondent | Amogh Kothare 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 | 2021-10-27 |
| Decision Date | 2022-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722022707 | K213461 | 000 |
| 00816722021700 | K213461 | 000 |