510(k) K160470
K160470 is an FDA 510(k) premarket notification submitted by Cynosure, Inc. for the device "SculpSure". The FDA issued a decision of Substantially Equivalent on July 21, 2016. The device falls under product code PKT (Laser For Disruption Of Adipocyte Cells For Aesthetic Use), a Class II device regulated under 21 CFR 878.5400. Cynosure, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 2016
- Date Received
- February 19, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- Device Class
- Class II
- Regulation Number
- 878.5400
- Review Panel
- SU
- Submission Type
Laser intended for the disruption of adipocyte cells indicated for body contouring or reduction in circumference of body areas.