cleadew GP hydra one— 510(k) K251876

Substantially Equivalent

Ophtecs Corporation

FDA 510(k) clearance K251876 for cleadew GP hydra one, Substantially Equivalent on 2025-10-09. Applicant: Ophtecs Corporation. Device class: 2.

Clearance details

Applicant: Ophtecs Corporation
Product code: Code MRC
Device class: Class 2
Regulation: 21 CFR 886.5918
Advisory panel: Ophthalmic
Date received: 2025-06-18
Decision date: 2025-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kobe, JP

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.