510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253822Substantially Equivalent

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

Zhuhai Fitlens Medical Technology Co., Ltd, Zhuhai, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253822 is the FDA 510(k) clearance record for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses, a class II device, cleared for Zhuhai Fitlens Medical Technology Co., Ltd. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list one 510(k) clearance for Zhuhai Fitlens Medical Technology Co., Ltd. As of , FDA records show no recalls naming K253822.

Clearance record

Decision date
Received
(119 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Zhuhai Fitlens Medical Technology Co., Ltd. Bldg. 6, # 129, Dingxing Rd., Tangjiawan Town, Zhuhai, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQD

Trailing 12 months
1 clearance under product code HQD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260