Cleared Traditional

K861746 - KEELER DUAL LIGHTSOURCE

K861746 is an FDA 510(k) clearance for KEELER DUAL LIGHTSOURCE, manufactured by Keeler Instruments, Inc.. The device is a Class 2 Ophthalmic device with product code HPQ cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K861746 · Keeler Instruments, Inc. · Ophthalmic device
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Aug 1986
Decision
107d
Days
Class 2
Risk

K861746 is an FDA 510(k) clearance for the KEELER DUAL LIGHTSOURCE. Classified as Headlamp, Operating, Ac-powered (product code HPQ), Class II - Special Controls.

Submitted by Keeler Instruments, Inc. (Broomall, US). The FDA issued a Cleared decision on August 21, 1986 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4335 - 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 Keeler Instruments, Inc. devices

FDA 510(k) Submission Details - K861746

510(k) Number K861746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1986
Decision Date August 21, 1986
Days to Decision 107 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 110d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HPQ Device Classification - Class 2, Special Controls

Product Code HPQ Headlamp, Operating, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4335
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.