The following data is part of a premarket notification filed by Ulthera, Inc with the FDA for The Cellfina System.
| Device ID | K192185 |
| 510k Number | K192185 |
| Device Name: | The Cellfina System |
| Classification | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Applicant | Ulthera, Inc 1840 S. Stapley Dr. Suite 200 Mesa, AZ 85204 |
| Contact | Lisa Pray |
| Correspondent | Lisa Pray Ulthera, Inc 1840 S. Stapley Dr. Suite 200 Mesa, AZ 85204 |
| Product Code | OUP |
| CFR Regulation Number | 878.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-12 |
| Decision Date | 2019-10-09 |
| Summary: | summary |