510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944313Substantially Equivalent

Spectacle Frame

Sun Hing Optical Manufactory Ltd., Kwun Tong, Kowloon, Hong Kong, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K944313 is the FDA 510(k) clearance record for SPECTACLE FRAME, a class I device, cleared for Sun Hing Optical Manufactory , Ltd. on under FDA product code HQZ (Frame, Spectacle). FDA records list one 510(k) clearance for Sun Hing Optical Manufactory , Ltd. As of , FDA records show no recalls naming K944313.

Clearance record

Decision date
Received
(211 days to decision)
Product code
HQZ Frame, Spectacle
Regulation
21 CFR 886.5842
Device class
Class I
Review panel
Ophthalmic
Applicant
Sun Hing Optical Manufactory , Ltd. Unit 1001c 10/F Sunbeam Center, Kwun Tong, Kowloon, Hong Kong, HK
510(k) summary
Summary
Third party review
No

Clearances, product code HQZ

Trailing 12 months

FDA records hold no clearances under product code HQZ in the trailing twelve months.

FDA records show no clearances under product code HQZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260