510(k) K083757
K083757 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BPZ02 MULTIPURPOSE SOLUTION". The FDA issued a decision of Substantially Equivalent on November 18, 2009. The device falls under product code LYL (Accessories, Solution, Ultrasonic Cleaners For Lenses), a Class II device regulated under 21 CFR 886.5928. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 18, 2009
- Date Received
- December 17, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Solution, Ultrasonic Cleaners For Lenses
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type