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510(k) K120028

AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES by Pegavision Corporation — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 2012
Date Received
January 4, 2012
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 Pegavision Corporation

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  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (May 8, 2024)
  • K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (May 31, 2023)
  • K211603 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquama (February 2, 2022)
  • K211448 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquama (December 6, 2021)
  • K200296 — Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lense (October 15, 2020)
  • K161739 — Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Sof (December 19, 2016)
  • K140025 — AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES (October 15, 2014)

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)