K192185 is an FDA 510(k) clearance for the The Cellfina System. This device is classified as a Powered Surgical Instrument For Improvement In The Appearance Of Cellulite (Class II - Special Controls, product code OUP).
Submitted by Ulthera, Inc. (Mesa, US). The FDA issued a Cleared decision on October 9, 2019, 58 days after receiving the submission on August 12, 2019.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4790. Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite..
| 510(k) Number | K192185 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2019 |
| Decision Date | October 09, 2019 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | OUP - Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4790 |
| Definition | Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite. |