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510(k) K112373

CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION by Innova Vision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2012
Date Received
August 17, 2011
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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  • K083288 — DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER (September 3, 2009)
  • K073060 — CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (November 29, 2007)
  • K062541 — CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS (June 7, 2007)
  • K053191 — DISCON DAILY (ETAFILCON A) ONE-DAY SOFT (HYDROPHILIC) CONTACT LENS (May 12, 2006)
  • K051129 — DISCON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (August 12, 2005)
  • K033136 — I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 (March 5, 2004)

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