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510(k) K100349

VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER by Johnson & Johnson Vision Care, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2010
Date Received
February 12, 2010
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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  • K180299 — ACUVUE OASYS (senofilcon A) with Photochromic Additive (April 10, 2018)
  • K160212 — ACUVUE (senofilcon C) Soft Contact Lens (March 28, 2016)
  • K141670 — ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA (September 18, 2014)
  • K073485 — VISTAKON (NARAFILCON) A SOFT CONTACT LENS (March 3, 2008)
  • K062614 — VISTAKON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, CLEAR AND TINTED (VISIBI (November 1, 2006)
  • K051900 — ACUVUE (ETAFILCON A) CONTACT LENS, CLEAR AND WITH VISIBILITY TINT WITH UV BLOCKE (August 12, 2005)
  • K032340 — VISTAKON (GALYFILCON A) SOFT CONTACT LENS (October 16, 2003)
  • K024177 — ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLO (January 22, 2003)

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