The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Genesisplus Laser System.
| Device ID | K103626 |
| 510k Number | K103626 |
| Device Name: | CUTERA GENESISPLUS LASER SYSTEM |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| 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 | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-10 |
| Decision Date | 2011-04-05 |
| Summary: | summary |