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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K253822
Device Name GPA (hexafocon A) Rigid Gas Permeable Contact Lenses
Applicant
Zhuhai Fitlens Medical Technology Co., Ltd.
Bldg. 6, # 129, Dingxing Rd., Tangjiawan Town
High-Tech Zone
Zhuhai,  CN 519080
Applicant Contact Grace Wang
Correspondent
Andre Vision and Device Research
6119 Canter Ln.
West Linn,  OR  97068
Correspondent Contact Bret Andre
Regulation Number886.5916
Classification Product Code
HQD  
Date Received11/28/2025
Decision Date 03/27/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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