510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930442Substantially Equivalent

Marco Gxx Series Photographic Slit Lamps

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

K930442 is the FDA 510(k) clearance record for MARCO GXX SERIES PHOTOGRAPHIC SLIT LAMPS, a class II device, cleared for Marco Ophthalmic, Inc. on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list 15 510(k) clearances for Marco Ophthalmic, Inc., from to . As of , FDA records show no recalls naming K930442.

Clearance record

Decision date
Received
(195 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Marco Ophthalmic, Inc. 11825 Central Pkwy., Jacksonville FL
510(k) summary
Statement
Third party review
No

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260