Boston One Step Liquid Enzymatic Cleaner

Products, Contact Lens Care, Rigid Gas Permeable

Bausch & Lomb Incorporated

The following data is part of a premarket notification filed by Bausch & Lomb Incorporated with the FDA for Boston One Step Liquid Enzymatic Cleaner.

Pre-market Notification Details

Device IDK200416
510k NumberK200416
Device Name:Boston One Step Liquid Enzymatic Cleaner
ClassificationProducts, Contact Lens Care, Rigid Gas Permeable
Applicant Bausch & Lomb Incorporated 400 Somerset Corporate Boulevard Bridgewater,  NJ  08807
ContactPinal Shah
CorrespondentPinal Shah
Bausch & Lomb Incorporated 400 Somerset Corporate Boulevard Bridgewater,  NJ  08807
Product CodeMRC  
CFR Regulation Number886.5918 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-20
Decision Date2020-09-23

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