510(k) K131208

BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, by Bausch & Lomb, Inc. — Product Code LPL

K131208 is an FDA 510(k) premarket notification submitted by Bausch & Lomb, Inc. for the device "BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA,". The FDA issued a decision of Substantially Equivalent on September 11, 2013. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Bausch & Lomb, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 2013
Date Received
April 29, 2013
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