510(k) K222541
K222541 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "Bausch + Lomb Preservative Free Lubricating and Rewetting Drops". The FDA issued a decision of Substantially Equivalent on December 6, 2022. The device falls under product code LPN (Accessories, Soft Lens Products), 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
- December 6, 2022
- Date Received
- August 22, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Soft Lens Products
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type