GPA (hexafocon A) Rigid Gas Permeable Contact Lenses— 510(k) K253822

Substantially Equivalent

Zhuhai Fitlens Medical Technology Co., Ltd.

FDA 510(k) clearance K253822 for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses, Substantially Equivalent on 2026-03-27. Applicant: Zhuhai Fitlens Medical Technology Co., Ltd..

Clearance details

Applicant: Zhuhai Fitlens Medical Technology Co., Ltd.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2025-11-28
Decision date: 2026-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zhuhai, CN

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