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Pegavision Corporation FDA Approvals

0 new drug approvals and 9 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses510(k)May 21, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 21, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses510(k)May 19, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Special)	May 19, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses510(k)Mar 13, 2026Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Mar 13, 2026
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses510(k)Sep 17, 2025Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Sep 17, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses510(k)Jul 2, 2025Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Jul 2, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses510(k)May 8, 2024Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 8, 2024
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)510(k)May 31, 2023Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	May 31, 2023
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses510(k)Feb 2, 2022Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Feb 2, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses510(k)Dec 6, 2021Ophthalmic	Ophthalmic	510(k)Substantially Equivalent (Traditional)	Dec 6, 2021

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