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510(k) K251876

cleadew GP hydra one by Ophtecs Corporation — Product Code MRC

K251876 is an FDA 510(k) premarket notification submitted by Ophtecs Corporation for the device "cleadew GP hydra one". The FDA issued a decision of Substantially Equivalent on October 9, 2025. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2025
Date Received
June 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type

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FDA data resources