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FDA 510(k)

cleadew GP hydra one

K-Number: K251876 · 2025-10-09

ApplicantOphtecs Corporation
Decision Date2025-10-09
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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