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
K854218Substantially Equivalent

The Ultra-Mate Lens

Optical Systems Intl., Inc., Hialeah FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854218 is the FDA 510(k) clearance record for THE ULTRA-MATE LENS, a class I device, cleared for Optical Systems Intl., Inc. on under FDA product code HQG (Lens, Spectacle, Non-Custom (Prescription)). FDA records list 2 510(k) clearances for Optical Systems Intl., Inc., from to . As of , FDA records show no recalls naming K854218.

Clearance record

Decision date
Received
(26 days to decision)
Product code
HQG Lens, Spectacle, Non-Custom (Prescription)
Regulation
21 CFR 886.5844
Device class
Class I
Review panel
Ophthalmic
Applicant
Optical Systems Intl., Inc. 1652 W. 32nd. Pl., Hialeah FL
Third party review
No

Clearances, product code HQG

Trailing 12 months

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

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