510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002044Substantially Equivalent

Magna Fortis Ophthalmoscope Diagnostic Kit

Magna Fortis Corporation, Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002044 is the FDA 510(k) clearance record for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT, a class II device, cleared for Magna Fortis Corporation on under FDA product code HLJ (Ophthalmoscope, Battery-Powered). FDA records list one 510(k) clearance for Magna Fortis Corporation. As of , FDA records show no recalls naming K002044.

Clearance record

Decision date
Received
(69 days to decision)
Product code
HLJ Ophthalmoscope, Battery-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Magna Fortis Corporation 13606 NE 20 St., Bellevue WA
510(k) summary
Summary
Third party review
No

Clearances, product code HLJ

Trailing 12 months

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

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