Cleared Traditional

K914484 - LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE

K914484 is an FDA 510(k) clearance for LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE, manufactured by Hgm Medical Laser Systems, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K914484 · Hgm Medical Laser Systems, Inc. · Ophthalmic device
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Jan 1992
Decision
90d
Days
Class 2
Risk

K914484 is an FDA 510(k) clearance for the LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPE. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Hgm Medical Laser Systems, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on January 6, 1992 after a review of 90 days - within the typical 510(k) review window.

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 Hgm Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K914484

510(k) Number K914484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1991
Decision Date January 06, 1992
Days to Decision 90 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 110d · This submission: 90d
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 28
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K914484.
R&D BATTERIES # 5615, 5234, 5097
K935988 · R & D Batteries, Inc. · Feb 1994
MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
K930023 · Welch Allyn, Inc. · Jun 1993
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742 · Carl Zeiss Meditec, Inc. · Mar 1993
ZEISS CONFOCAL LASER SCANNING OPHTHALMOSCOPE(CLSO)
K912581 · Carl Zeiss, Inc. · Dec 1991
KEELER KONAN SPECULAR MICROSCOPE SP3300
K900111 · Keeler Instruments, Inc. · Mar 1990
VISTA OPHTHALMOSCOPE (BATTERY AND AC-POWERED)
K893172 · Keeler Instruments, Inc. · Jun 1989