510(k) K170052
K170052 is an FDA 510(k) premarket notification submitted by Bausch+Lomb for the device "Stellaris Elite vision enhancement system". The FDA issued a decision of Substantially Equivalent on Apr 19, 2017. The device falls under product code HQC (Unit, Phacofragmentation), a Class II device regulated under 21 CFR 886.4670. Bausch+Lomb has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 19, 2017
- Date Received
- Jan 5, 2017
- Clearance Type
- Traditional
- 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
- 510(k)