510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K896350Substantially Equivalent

Titan Air Spectacle Frame

Acces Intl. Eyewear, West Palm Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896350 is the FDA 510(k) clearance record for TITAN AIR SPECTACLE FRAME, a class II device, cleared for Acces Intl. Eyewear on under FDA product code HQJ (Implant, Absorbable, (Scleral Buckling Methods)). FDA records list 2 510(k) clearances for Acces Intl. Eyewear, from to . As of , FDA records show no recalls naming K896350.

Clearance record

Decision date
Received
(42 days to decision)
Product code
HQJ Implant, Absorbable, (Scleral Buckling Methods)
Regulation
21 CFR 886.3300
Device class
Class II
Review panel
Ophthalmic
Applicant
Acces Intl. Eyewear 444 Bunker Rd., West Palm Beach FL
Third party review
No

Clearances, product code HQJ

Trailing 12 months

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

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