The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Genesisplus.
| Device ID | K122493 |
| 510k Number | K122493 |
| Device Name: | GENESISPLUS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Contact | Connie Hoy |
| Correspondent | Connie Hoy 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 | 2012-08-16 |
| Decision Date | 2013-05-15 |
| Summary: | summary |