510(k) K090754
K090754 is an FDA 510(k) premarket notification submitted by Osyris Medical for the device "LIPOCONTROL". The FDA issued a decision of Substantially Equivalent on January 21, 2011. The device falls under product code ORK (Laser Assisted Lipolysis), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2011
- Date Received
- March 20, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser Assisted Lipolysis
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Intended to be used for laser assisted lipolysis