FDA 510(k)

Lunettes de Contact AQUASPLASH (Polymacon) Douces (Hydrophiles) à Porter Quotidiennement

Numéro K : K210609 · 2021-04-27

Date de décision2021-04-27

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Vp Optics. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K210609. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Vp Optics. The 510(k) number is K210609.

When did AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens receive FDA 510(k) clearance?

AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens received FDA 510(k) clearance on 2021-04-27, under 510(k) number K210609.

Who is the listed applicant for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA 510(k) record lists Vp Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens?

The FDA product code for AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens is LPL.

Essais cliniques associés

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Dispositifs connexes (Code : LPL)

Source officielle

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