510(k) K101325
K101325 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "STELLARIS PC VISION ENHANCEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on August 17, 2010. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2010
- Date Received
- May 12, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type