510(k) K123407
K123407 is an FDA 510(k) premarket notification submitted by Cynosure, Inc. for the device "CELLULAZE LASER". The FDA issued a decision of Substantially Equivalent on March 29, 2013. The device falls under product code OYW (Laser, Cellulite Appearance), a Class II device regulated under 21 CFR 878.4810. Cynosure, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2013
- Date Received
- November 5, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Cellulite Appearance
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
For the removal of fat through laser lipolysis.