510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K943840Substantially Equivalent

(Brand Name0 Mondain

Chan'S Plastic Manufactory Co., Ltd., Hong Kong, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943840 is the FDA 510(k) clearance record for (BRAND NAME0 MONDAIN, a class I device, cleared for Chan'S Plastic Manufactory Co., Ltd. on under FDA product code HQY (Sunglasses (Non-Prescription Including Photosensitive)). FDA records list one 510(k) clearance for Chan'S Plastic Manufactory Co., Ltd. As of , FDA records show no recalls naming K943840.

Clearance record

Decision date
Received
(32 days to decision)
Product code
HQY Sunglasses (Non-Prescription Including Photosensitive)
Regulation
21 CFR 886.5850
Device class
Class I
Review panel
Ophthalmic
Applicant
Chan'S Plastic Manufactory Co., Ltd. Unit 01, 6/F, Hong Man Ind Ctr, Hong Kong, HK
510(k) summary
Statement
Third party review
No

Clearances, product code HQY

Trailing 12 months

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

FDA records show no clearances under product code HQY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HQY, 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