510(k) K134010
K134010 is an FDA 510(k) premarket notification submitted by Cabochon Aesthetics, Inc. for the device "CABOCHON SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 2014. 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. Cabochon Aesthetics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 2014
- Date Received
- December 30, 2013
- 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.