510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854442Substantially Equivalent

Uvasorb-400

Optatint, Inc., Englewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854442 is the FDA 510(k) clearance record for UVASORB-400, cleared for Optatint, Inc. on under FDA product code HPX (Lens, Contact (Polymethylmethacrylate)). FDA records list 2 510(k) clearances for Optatint, Inc., from to . As of , FDA records show no recalls naming K854442.

Clearance record

Decision date
Received
(106 days to decision)
Product code
HPX Lens, Contact (Polymethylmethacrylate)
Device class
Unclassified
Review panel
Unknown
Applicant
Optatint, Inc. 2890 S. Tejon St., Englewood CO
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