Cleared Traditional

K923708 - LEMPERT OPTIC DISC ANALYSIS SYSTEM

K923708 is an FDA 510(k) clearance for LEMPERT OPTIC DISC ANALYSIS SYSTEM, manufactured by Lempert Ophthalmic Instruments. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K923708 · Lempert Ophthalmic Instruments · Ophthalmic device
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Mar 1993
Decision
235d
Days
Class 2
Risk

K923708 is an FDA 510(k) clearance for the LEMPERT OPTIC DISC ANALYSIS SYSTEM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Lempert Ophthalmic Instruments (Ithaca, US). The FDA issued a Cleared decision on March 19, 1993 after a review of 235 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - 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 Lempert Ophthalmic Instruments devices

FDA 510(k) Submission Details - K923708

510(k) Number K923708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1992
Decision Date March 19, 1993
Days to Decision 235 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
125d slower than avg
Panel avg: 110d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKI Device Classification - Class 2, Special Controls

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
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 - HKI Camera, Ophthalmic, Ac-powered

All 113
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K923708.
NON-MYDRIATIC RETINAL CAMERA
K941234 · Canon USA, Inc. · Jun 1995
60 FUNDUS CAMERA CF-60UV
K946058 · Canon USA, Inc. · Feb 1995
60 DEGREE FUNDUS CAMERA, CF-60UD
K934663 · Canon USA, Inc. · Feb 1994
CANDELA RETINAL CAMERA
K913314 · Candela Laser Corp. · Jan 1992
NON-MYDRIATIC RETINAL CAMERA, CR-45UAF
K911439 · Canon USA, Inc. · Jun 1991
NON-MYDRIATIC RETINAL CAMERA, CR4-45NM DUAL
K895474 · Canon USA, Inc. · Oct 1989