FDA 510(k)

cleadew GP hydra one

Numéro K : K251876 · 2025-10-09

Date de décision2025-10-09

Code produitMRC

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

cleadew GP hydra one is the device name listed in this FDA 510(k) record. The listed applicant is Ophtecs Corporation. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K251876. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the cleadew GP hydra one?

cleadew GP hydra one is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Ophtecs Corporation. The 510(k) number is K251876.

When did cleadew GP hydra one receive FDA 510(k) clearance?

cleadew GP hydra one received FDA 510(k) clearance on 2025-10-09, under 510(k) number K251876.

Who is the listed applicant for cleadew GP hydra one?

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

What is the FDA product code for cleadew GP hydra one?

The FDA product code for cleadew GP hydra one is MRC.

Essais cliniques associés

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Source officielle

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