Cleared Traditional

cleadew GP hydra one

K251876 · Ophtecs Corporation · Ophthalmic

Oct 2025

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K251876 is an FDA 510(k) clearance for the cleadew GP hydra one, a Products, Contact Lens Care, Rigid Gas Permeable (Class II — Special Controls, product code MRC), submitted by Ophtecs Corporation (Kobe, JP). The FDA issued a Cleared decision on October 9, 2025, 113 days after receiving the submission on June 18, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5918.

Submission Details

510(k) Number	K251876 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 18, 2025
Decision Date	October 09, 2025
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF