Cleared Traditional

K992606 - CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100

K992606 is an FDA 510(k) clearance for CANON LASER BLOOD FLOWMETER (CLBF) MODE..., manufactured by Canon USA, Inc.. The device is a Class 2 Ophthalmic device with product code HLI cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K992606 · Canon USA, Inc. · Ophthalmic device
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Jun 2000
Decision
323d
Days
Class 2
Risk

K992606 is an FDA 510(k) clearance for the CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on June 21, 2000 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Canon USA, Inc. devices

FDA 510(k) Submission Details - K992606

510(k) Number K992606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1999
Decision Date June 21, 2000
Days to Decision 323 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
213d slower than avg
Panel avg: 110d · This submission: 323d
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 72
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