510(k) K232153
- Device
- Avéli
- Applicant
- Revelle Aesthetics, Inc.
- 510(k) number
- K232153
- Product code
- OUP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-08-18
- Date received
- 2023-07-19
- Regulation
- 878.4790
- Classification name
- Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Melissa Viotti
- Address
- 2570 W. El Camino Real, Suite 310 Mountain View CA US 94040 94040
FDA Registration Numbers#
- 3043011436
- 1721676
- 3003707320
- 3023808190
- 3017132875
- 3043012074
- 3043012240
- 3043149902
- 3013840437
- 3010273872
- 3015452693
- 3009905888
- 3043657394
- 3003678543
- 3042228064
- 3031233197
Source Documents#
Other 510(k) Records For Product Code OUP#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221336 | Avéli | Revelle Aesthetics, Inc. | 2022-08-05 |
| K212399 | Aveli | Nc8, Inc. | 2021-10-22 |
| K192185 | The Cellfina System | Ulthera, Inc. | 2019-10-09 |
| K161885 | The Cellfina System | Ulthera, Inc. | 2016-10-05 |
| K153677 | The Cellfina System | Ulthera, Inc. | 2016-02-25 |
| K150505 | Cellfina System | Ulthera, Inc. | 2015-07-29 |
| K134010 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | 2014-04-14 |
| DEN110004 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | 2013-07-12 |