510(k) K180319
K180319 is an FDA 510(k) premarket notification submitted by Bausch and Lomb, Incorporated for the device "Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution". The FDA issued a decision of Substantially Equivalent on March 27, 2018. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Bausch and Lomb, Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 27, 2018
- Date Received
- February 5, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Products, Contact Lens Care, Rigid Gas Permeable
- Device Class
- Class II
- Regulation Number
- 886.5918
- Review Panel
- OP
- Submission Type