Home / 510(k) Clearances / K151918

510(k) K151918

Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist by Bausch & Lomb, Incorporated — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2016
Date Received
July 13, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

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