The following data is part of a premarket notification filed by Cabochon Aesthetics, Inc. with the FDA for Cabochon System.
| Device ID | K134010 |
| 510k Number | K134010 |
| Device Name: | CABOCHON SYSTEM |
| Classification | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Applicant | CABOCHON AESTHETICS, INC. 127 Independence Drive Menlo Park, CA 94025 |
| Contact | Ben F Brian, Ph.d. |
| Correspondent | Ben F Brian, Ph.d. CABOCHON AESTHETICS, INC. 127 Independence Drive Menlo Park, CA 94025 |
| Product Code | OUP |
| CFR Regulation Number | 878.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-30 |
| Decision Date | 2014-04-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840763100124 | K134010 | 000 |
| 00840763100117 | K134010 | 000 |
| 00840763100094 | K134010 | 000 |