Home / 510(k) Clearances / K200243

510(k) K200243

ACUVUE (senofilcon A) Soft Contact Lens Multifocal by Johnson & Johnson Vision Care, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2020
Date Received
January 31, 2020
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.

  • K210930 — ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) (November 29, 2021)
  • 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)
  • 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)

Other clearances for product code LPL

  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Bl (December 23, 2025)
  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 2025)
  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (September 10, 2025)
  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDEN (April 17, 2025)