The following data is part of a premarket notification filed by Ulthera, Inc. with the FDA for The Cellfina System.
| Device ID | K153677 |
| 510k Number | K153677 |
| 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 | Suzon Lommel |
| Correspondent | Suzon Lommel ULTHERA, INC. 1840 S Stapley Dr, Suite 200 Mesa, AZ 85204 |
| Product Code | OUP |
| CFR Regulation Number | 878.4790 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840763100568 | K153677 | 000 |
| 00840763100544 | K153677 | 000 |
| 00840763100537 | K153677 | 000 |
| 00840763100377 | K153677 | 000 |
| 00840763100087 | K153677 | 000 |
| 10840763100107 | K153677 | 000 |