510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K873965Substantially Equivalent

Frame, Spectacle

Swank Plus, Ltd., Hong Kong, HK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K873965 is the FDA 510(k) clearance record for FRAME, SPECTACLE, a class I device, cleared for Swank Plus , Ltd. on under FDA product code HQZ (Frame, Spectacle). FDA records list 3 510(k) clearances for Swank Plus , Ltd., from to . As of , FDA records show no recalls naming K873965.

Clearance record

Decision date
Received
(185 days to decision)
Product code
HQZ Frame, Spectacle
Regulation
21 CFR 886.5842
Device class
Class I
Review panel
Ophthalmic
Applicant
Swank Plus , Ltd. P.O. Box 70750, Hong Kong, HK
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