510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930446Substantially Equivalent

Marco Trial Sets

Marco Ophthalmic, Inc., Jacksonville FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K930446 is the FDA 510(k) clearance record for MARCO TRIAL SETS, a class I device, cleared for Marco Ophthalmic, Inc. on under FDA product code HPC (Set, Lens, Trial, Ophthalmic). FDA records list 15 510(k) clearances for Marco Ophthalmic, Inc., from to . As of , FDA records show no recalls naming K930446.

Clearance record

Decision date
Received
(161 days to decision)
Product code
HPC Set, Lens, Trial, Ophthalmic
Regulation
21 CFR 886.1405
Device class
Class I
Review panel
Ophthalmic
Applicant
Marco Ophthalmic, Inc. 11825 Central Pkwy., Jacksonville FL
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