510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930195Substantially Equivalent

Ophthalmic Trial Lenses

Optimark Accessories and Instruments, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930195 is the FDA 510(k) clearance record for OPHTHALMIC TRIAL LENSES, a class I device, cleared for Optimark Accessories and Instruments on under FDA product code HPC (Set, Lens, Trial, Ophthalmic). FDA records list one 510(k) clearance for Optimark Accessories and Instruments. As of , FDA records show no recalls naming K930195.

Clearance record

Decision date
Received
(357 days to decision)
Product code
HPC Set, Lens, Trial, Ophthalmic
Regulation
21 CFR 886.1405
Device class
Class I
Review panel
Ophthalmic
Applicant
Optimark Accessories and Instruments P.O. Box 14115, Seattle WA
510(k) summary
Statement
Third party review
No

Clearances, product code HPC

Trailing 12 months

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

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