510(k) K192185
- Device
- The Cellfina System
- Applicant
- Ulthera, Inc
- 510(k) number
- K192185
- Product code
- OUP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-10-09
- Date received
- 2019-08-12
- 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
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Lisa Pray
- Address
- 1840 S. Stapley Dr. Suite 200 Mesa AZ US 85204 85204
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 |
|---|---|---|---|
| K232153 | Avéli | Revelle Aesthetics, Inc. | 2023-08-18 |
| K221336 | Avéli | Revelle Aesthetics, Inc. | 2022-08-05 |
| K212399 | Aveli | Nc8, Inc. | 2021-10-22 |
| 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 |
Legacy Summary#
summary
FDA Review#
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