Cleared Traditional

K843897 - POCKET OPHTHALMOSCOPE GH

K843897 is the FDA 510(k) clearance for POCKET OPHTHALMOSCOPE GH by Design Med. Corp.. It is a Class 2 Ophthalmic device (product code HLJ) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K843897 · Design Med. Corp. · Ophthalmic device
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Nov 1984
Decision
55d
Days
Class 2
Risk

K843897 is an FDA 510(k) clearance for the POCKET OPHTHALMOSCOPE GH. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Design Med. Corp. (Lake Forest, US). The FDA issued a Cleared decision on November 27, 1984 after a review of 55 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.

View all Design Med. Corp. devices

Submission Details

510(k) Number K843897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1984
Decision Date November 27, 1984
Days to Decision 55 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 110d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K843897.
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018 · R & D Batteries, Inc. · Feb 1994
R & D BATTERIES
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INDIRECT OPHTHALMOSCOPE
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MEDIC LUX DIAGNOSTIC SETS
K832437 · Keeler Instruments, Inc. · Aug 1983
DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP
K830215 · Jedmed Instrument Co. · Mar 1983
SOLA COMMIDO LOUPE
K760770 · Codman & Shurtleff, Inc. · Oct 1976