The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Solera Opus Aesthetic Product.
| Device ID | K050679 |
| 510k Number | K050679 |
| Device Name: | CUTERA SOLERA OPUS AESTHETIC PRODUCT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD. Brisbane, CA 94005 |
| Contact | Kathy Maynor |
| Correspondent | Morten Simon Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-03-16 |
| Decision Date | 2005-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722021908 | K050679 | 000 |