← FDA Medical Device Classifications
Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
OUP · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4790
Classification
- FDA Product Code
OUP- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 878.4790
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.
Market data
- Cleared 510(k) submissions
- 9
- Registered establishments
- 16
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown