510(k) K173365
K173365 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "Bausch + Lomb Boston Scleral Lens Case". The FDA issued a decision of Substantially Equivalent on November 17, 2017. The device falls under product code LRX (Case, Contact Lens), a Class II device regulated under 21 CFR 886.5928. Bausch & Lomb, Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2017
- Date Received
- October 26, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Case, Contact Lens
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type