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 a medical device manufactured by Ophtecs Corporation. It received FDA 510(k) clearance on 2025-10-09 under approval 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. It is manufactured by Ophtecs Corporation. The 510(k) number is K251876.
When was cleadew GP hydra one approved by the FDA?
cleadew GP hydra one received FDA 510(k) clearance on 2025-10-09, under approval number K251876.
What company makes cleadew GP hydra one?
cleadew GP hydra one is manufactured by Ophtecs Corporation.
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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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.