510(k) K192185
K192185 is an FDA 510(k) premarket notification submitted by Ulthera, Inc. for the device "The Cellfina System". The FDA issued a decision of Substantially Equivalent on October 9, 2019. The device falls under product code OUP (Powered Surgical Instrument For Improvement In The Appearance Of Cellulite), a Class II device regulated under 21 CFR 878.4790. Ulthera, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2019
- Date Received
- August 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
- Device Class
- Class II
- Regulation Number
- 878.4790
- Review Panel
- SU
- Submission Type
Used for controlled release of subcutaneous tissue for improvement in the appearance of cellulite.