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
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K811010Substantially Equivalent

Contact Lens Materl

Paragon Optical Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K811010 is the FDA 510(k) clearance record for CONTACT LENS MATERL, cleared for Paragon Optical Co. on under FDA product code HPX (Lens, Contact (Polymethylmethacrylate)). FDA records list one 510(k) clearance for Paragon Optical Co. As of , FDA records show no recalls naming K811010.

Clearance record

Decision date
Received
(238 days to decision)
Product code
HPX Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified
Review panel
Unknown
Applicant
Paragon Optical Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HPX

Trailing 12 months

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

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