The following data is part of a premarket notification filed by Cutera, Inc. with the FDA for Cutera Multimodal Cellulite Product (cmmcd).
| Device ID | K080300 |
| 510k Number | K080300 |
| Device Name: | CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) |
| Classification | Massager, Vacuum, Light Induced Heating |
| Applicant | CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor CUTERA, INC. 3240 BAYSHORE BLVD Brisbane, CA 94005 |
| Product Code | NUV |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-05 |
| Decision Date | 2008-04-08 |
| Summary: | summary |