Cleared Traditional

K913852 - LASER FLARE METER

K913852 is an FDA 510(k) clearance for LASER FLARE METER, manufactured by Kowa Optimed, Inc.. The device is a Class 2 Ophthalmic device with product code HJO cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K913852 · Kowa Optimed, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
164d
Days
Class 2
Risk

K913852 is an FDA 510(k) clearance for the LASER FLARE METER. Classified as Biomicroscope, Slit-lamp, Ac-powered (product code HJO), Class II - Special Controls.

Submitted by Kowa Optimed, Inc. (Torrance, US). The FDA issued a Cleared decision on February 7, 1992 after a review of 164 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - 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 Kowa Optimed, Inc. devices

FDA 510(k) Submission Details - K913852

510(k) Number K913852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1991
Decision Date February 07, 1992
Days to Decision 164 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
54d slower than avg
Panel avg: 110d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HJO Device Classification - Class 2, Special Controls

Product Code HJO Biomicroscope, Slit-lamp, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
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 - HJO Biomicroscope, Slit-lamp, Ac-powered

All 77
Devices cleared under the same product code (HJO) and FDA review panel - the closest regulatory comparables to K913852.
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