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510(k) K073621

INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT by Art Optical Contact Lens, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2008
Date Received
December 26, 2007
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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  • K152046 — Intelliwave4 with HPT, Silicone Hydrogel Daily Wear Soft Contact Lens (safrofilc (November 24, 2015)
  • K142641 — Intelliwave4 (January 12, 2015)
  • K100221 — INTELLIWAVE3 (September 14, 2010)

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