Cleared Traditional

K950797 - HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134

K950797 is an FDA 510(k) clearance for HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134, manufactured by Neitz Instruments Company, Ltd.. The device is a Class 2 Ophthalmic device with product code HLJ cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K950797 · Neitz Instruments Company, Ltd. · Ophthalmic device
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Mar 1995
Decision
35d
Days
Class 2
Risk

K950797 is an FDA 510(k) clearance for the HALOGEN OPHTHALMO-OTOSCOPE SET BX A - 134. Classified as Ophthalmoscope, Battery-powered (product code HLJ), Class II - Special Controls.

Submitted by Neitz Instruments Company, Ltd. (Tokyo, JP). The FDA issued a Cleared decision on March 28, 1995 after a review of 35 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 Neitz Instruments Company, Ltd. devices

FDA 510(k) Submission Details - K950797

510(k) Number K950797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1995
Decision Date March 28, 1995
Days to Decision 35 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 110d · This submission: 35d
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 19
Devices cleared under the same product code (HLJ) and FDA review panel - the closest regulatory comparables to K950797.
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
RI-SCOPE S OTOSCOPE
K945640 · Rudolf Riester GmbH & Co. KG · Jan 1995
R&D BATTERIES, PART NOS. 5135, 5097, 5444, AND 5502
K942034 · R & D Batteries, Inc. · Jun 1994
REPLACEMENT BATTERIES PART NO. 5098,5135, 5097
K936018 · R & D Batteries, Inc. · Feb 1994