Cleared Abbreviated

CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ (K994340) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K994340 · Hai Laboratories, Inc. · Ophthalmic device
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Sep 2000
Decision
272d
Days
Class 2
Risk

K994340 is an FDA 510(k) clearance for the CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Hai Laboratories, Inc. (Sound Beach, US). The FDA issued a Cleared decision on September 20, 2000 after a review of 272 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Hai Laboratories, Inc. devices

Submission Details

510(k) Number K994340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1999
Decision Date September 20, 2000
Days to Decision 272 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 110d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.