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510(k) K232139

Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens by Innova Vision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2023
Date Received
July 18, 2023
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 Innova Vision, Inc.

  • K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Cont (April 17, 2024)
  • K222954 — Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens (March 13, 2023)
  • K213119 — Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (May 13, 2022)
  • K112373 — CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODI (August 17, 2012)
  • 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)

Other clearances for product code LPL

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  • 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)