510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K802593Substantially Equivalent

Keratoplasty Suturing Lens

Paris Contact Lens Laboratory, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802593 is the FDA 510(k) clearance record for KERATOPLASTY SUTURING LENS, cleared for Paris Contact Lens Laboratory on under FDA product code HPX (Lens, Contact (Polymethylmethacrylate)). FDA records list one 510(k) clearance for Paris Contact Lens Laboratory. As of , FDA records show no recalls naming K802593.

Clearance record

Decision date
Received
(62 days to decision)
Product code
HPX Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified
Review panel
Unknown
Applicant
Paris Contact Lens Laboratory 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