510(k) K251876— cleadew GP hydra one

Substantially Equivalent

Ophtecs Corporation

Clearance details

Applicant: Ophtecs Corporation
Product code: Code MRC
Advisory panel: Ophthalmic
Date received: 2025-06-18
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kobe, JP

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