OUP · Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
General, Plastic Surgery · 21 CFR 878.4790 · Class 2
Overview
| Product Code | OUP |
|---|---|
| Device Name | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Regulation | 21 CFR 878.4790 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
A powered surgical instrument for improvement in the appearance of cellulite is a prescription device that is used for the controlled release of subcutaneous tissue for improvement in the appearance of cellulite. The device consists of a cutting tool powered by a motor and a means for instrument guidance to control the areas of subcutaneous tissue cutting underneath the cellulite depressions or dimples.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
In addition to the general controls of the FD&C Act, the Cabochon System is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical testing must be performed to demonstrate that the device meets all design specifications and performance requirements, and to demonstrate durability and mechanical integrity of the device. (2) In vivo evaluation of the device must demonstrate device performance, including the safety of the release methodology and blood loss at the treatment sites. (3) All elements of the device that may contact the patient must be demonstrated to be biocompatible. (4) Electrical safety and electromagnetic compatibility of the device must be demonstrated. (5) The labeling must include a summary of in vivo evaluation data and all the device specific warnings, precautions, and/or contraindications. (6) Sterility and shelf-life testing for the device must demonstrate the sterility of patient contacting components and the shelf life of these components.
Recent Cleared Devices (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232153 | Avéli | Revelle Aesthetics, Inc. | Aug 18, 2023 | SESE |
| K221336 | Avéli | Revelle Aesthetics, Inc. | Aug 5, 2022 | SESE |
| K212399 | Aveli | Nc8, Inc. | Oct 22, 2021 | SESE |
| K192185 | The Cellfina System | Ulthera, Inc. | Oct 9, 2019 | SESE |
| K161885 | The Cellfina System | Ulthera, Inc. | Oct 5, 2016 | SESE |
| K153677 | The Cellfina System | Ulthera, Inc. | Feb 25, 2016 | SESE |
| K150505 | Cellfina System | Ulthera, Inc. | Jul 29, 2015 | SESE |
| K134010 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | Apr 14, 2014 | SESE |
| DEN110004 | CABOCHON SYSTEM | Cabochon Aesthetics, Inc. | Jul 12, 2013 | DENG |
Top Applicants
- Ulthera, Inc. — 4 clearances
- Revelle Aesthetics, Inc. — 2 clearances
- Cabochon Aesthetics, Inc. — 2 clearances
- Nc8, Inc. — 1 clearance
