FDA 510(k) Applications Submitted by PEGAVISION CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K200296 02/06/2020 Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses Pegavision Corporation
K211448 05/10/2021 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses Pegavision Corporation
K211603 05/24/2021 Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses Pegavision Corporation
K222885 09/23/2022 Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) Pegavision Corporation
K161739 06/24/2016 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses PEGAVISION CORPORATION
K120028 01/04/2012 AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES Pegavision Corporation
K140025 01/06/2014 AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation
K123973 12/26/2012 AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES Pegavision Corporation


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