Cleared Traditional

K002044 - MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT

K002044 is an FDA 510(k) clearance for MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT, manufactured by Magna Fortis Corporation. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K002044 · Magna Fortis Corporation · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
69d
Days
Class 2
Risk

K002044 is an FDA 510(k) clearance for the MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Magna Fortis Corporation (Bellevue, US). The FDA issued a Cleared decision on September 12, 2000 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K002044

510(k) Number K002044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2000
Decision Date September 12, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 110d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLJ Device Classification - Class 2, Special Controls

Product Code HLJ Ophthalmoscope, Battery-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HLJ Ophthalmoscope, Battery-powered

All 46
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K002044.
OPTYSE OPHTHALMOSCOPE
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MS401097-17,MS722-K,MS720,MS721,MS722
K962767 · Alexander Mfg. Co. · Jul 1997
KEELER SPECTRA INDIRECT OPHTHALMOSCOPE
K970029 · Keeler Instruments, Inc. · Apr 1997
RI-FORMER WALL MODEL 2,5 V/220 V OR 110 V 3,5 V/220 V OR 110 V, RI-FORMER ANAESTHETIC MODEL 2,5 V/220 V OR 110 C 3,5 V/V
K950914 · Rudolf Riester GmbH & Co. KG · Jul 1995
K002044 · MAGNA FORTIS OPHTHALMOSCOPE DIAGNOSTIC KIT
Download PDF FDA Summary Magna Fortis Corporat…