510(k) K200416

Boston One Step Liquid Enzymatic Cleaner by Bausch & Lomb, Incorporated — Product Code MRC

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