Cleared Traditional

K862866 - MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K862866 · Directed Energy, Inc. · Ear, Nose, Throat device
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Jan 1987
Decision
164d
Days
Class 2
Risk

K862866 is an FDA 510(k) clearance for the MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Directed Energy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 9, 1987 after a review of 164 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4500 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Directed Energy, Inc. devices

Submission Details

510(k) Number K862866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1986
Decision Date January 09, 1987
Days to Decision 164 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 89d · This submission: 164d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EWG Laser, Ent Microsurgical Carbon-dioxide
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4500
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 Ear, Nose, Throat devices follow this clearance model.