510(k) K200416
K200416 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Incorporated for the device "Boston One Step Liquid Enzymatic Cleaner". The FDA issued a decision of Substantially Equivalent on September 23, 2020. 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 & Lomb, Incorporated has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 2020
- Date Received
- February 20, 2020
- 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