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510(k) K032340

VISTAKON (GALYFILCON A) SOFT CONTACT LENS by Johnson & Johnson Vision Care, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2003
Date Received
July 29, 2003
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

Other clearances by Johnson & Johnson Vision Care, Inc.

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  • K200243 — ACUVUE (senofilcon A) Soft Contact Lens Multifocal (March 17, 2020)
  • 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)
  • K100349 — VISTAKON (NARAFILCON B) CONTACT LENS VISIBILITY TINTED WITH UV BLOCKER (May 21, 2010)
  • 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)
  • K024177 — ACUVUE 2 COLOURS BRAND (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLO (January 22, 2003)

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