510(k) K230954
K230954 is an FDA 510(k) premarket notification submitted by Bausch + Lomb, Incorporated for the device "Samfilcon B Custom Contact Lens". The FDA issued a decision of Substantially Equivalent on November 17, 2023. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Bausch + Lomb, Incorporated has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2023
- Date Received
- April 4, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type