Cleared Traditional

K930023 - MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE

K930023 is an FDA 510(k) clearance for MODEL #12000 BINOCULAR INDERECT OPHTHAL..., manufactured by Welch Allyn, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 167-day FDA review.

K930023 · Welch Allyn, Inc. · Ophthalmic device
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Jun 1993
Decision
167d
Days
Class 2
Risk

K930023 is an FDA 510(k) clearance for the MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on June 21, 1993 after a review of 167 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Welch Allyn, Inc. devices

FDA 510(k) Submission Details - K930023

510(k) Number K930023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1993
Decision Date June 21, 1993
Days to Decision 167 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
57d slower than avg
Panel avg: 110d · This submission: 167d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HLI Device Classification - Class 2, Special Controls

Product Code HLI Ophthalmoscope, Ac-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 - HLI Ophthalmoscope, Ac-powered

All 70
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K930023.
KEELER VANTAGE INDIRECT OPHTHALMOSCOPE
K942104 · Keeler Instruments, Inc. · Aug 1994
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K941705 · Carl Zeiss Meditec, Inc. · Jul 1994
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K935988 · R & D Batteries, Inc. · Feb 1994
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742 · Carl Zeiss Meditec, Inc. · Mar 1993
LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE
K914484 · Hgm Medical Laser Systems, Inc. · Jan 1992
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · Carl Zeiss, Inc. · Dec 1991