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510(k) K123202

PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS by CooperVision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 2013
Date Received
October 12, 2012
Clearance Type
Special
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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  • K190965 — MyDay (April 29, 2019)
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  • K133627 — AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS (December 23, 2013)
  • K131378 — SUS (STENFILCON A) CONTACT LENS (August 30, 2013)

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