510(k) K133242
K133242 is an FDA 510(k) premarket notification submitted by Bausch & Lomb for the device "STELLARIS VISION ENHANCEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on February 14, 2014. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Bausch & Lomb has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 14, 2014
- Date Received
- October 21, 2013
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Phacofragmentation
- Device Class
- Class II
- Regulation Number
- 886.4670
- Review Panel
- OP
- Submission Type