Definition: Used For Controlled Release Of Subcutaneous Tissue For Improvement In The Appearance Of Cellulite.
| Device Type ID | 5828 |
| Device Name | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Physical State | The Device Consists Of A Cutting Blade Powered By A Motor And A Means For Instrument Guidance To Control The Areas Of Subcutaneous Tissue Cutting Underneath The Cellulite Depressions Or Dimples. |
| Technical Method | The Device Temporarily Improves The Appearance Of Cellulite By Controlled Release (cutting) Of The Subcutaneous Tissue Underneath The Cellulite Depressions Or Dimples. |
| Target Area | Area With Cellulite, Fibrous Septae, Fat, Soft Tissue. |
| Regulation Description | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) General Surgery Devices Branch Two - Surgical (GSDB2) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.4790 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OUP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5828 |
| Device | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite |
| Product Code | OUP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Surgical Instrument For Improvement In The Appearance Of Cellulite. |
| CFR Regulation Number | 878.4790 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CABOCHON AESTHETICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ULTHERA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 10 |
Physical Property Issue | 1 |
Appropriate Term/Code Not Available | 1 |
Break | 1 |
Insufficient Information | 1 |
| Total Device Problems | 14 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ulthera Inc | II | Dec-13-2016 |