510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K024164Substantially Equivalent

Comfortkone Keratoconus Aspheric (Hybufocon a, Filofilcon a, Pemufocon a) Rigid Gas Permeable (Rgp) Daily Wear Contact

Metro Optics, Inc., Grand Junction CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K024164 is the FDA 510(k) clearance record for COMFORTKONE KERATOCONUS ASPHERIC (HYBUFOCON A, FILOFILCON A, PEMUFOCON A) RIGID GAS PERMEABLE (RGP) DAILY WEAR CONTACT, a class II device, cleared for Metro Optics, Inc. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list one 510(k) clearance for Metro Optics, Inc. As of , FDA records show no recalls naming K024164.

Clearance record

Decision date
Received
(57 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Metro Optics, Inc. 623 Glacier Dr., Grand Junction CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQD

Trailing 12 months
1 clearance under product code HQD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260