Cleared Traditional

K862866 - MODEL 10-C W/LP-10A/U & OS-10A/U FOR OR...

K862866 is an FDA 510(k) clearance for MODEL 10-C W/LP-10A/U & OS-10A/U FOR OR..., manufactured by Directed Energy, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 164-day FDA review.

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

FDA 510(k) Submission Details - K862866

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
Combination Product No
PCCP Authorized No
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.

EWG Device Classification - Class 2, Special Controls

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.

Regulatory Peers - EWG Laser, Ent Microsurgical Carbon-dioxide

All 13
Devices cleared under the same product code (EWG) and FDA review panel - the closest regulatory comparables to K862866.
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.O ATTACH
K870840 · Directed Energy, Inc. · Jun 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM FOR (ENT)
K864975 · Laserscope · Feb 1987
MODEL 10-C W/LP-10A/U & OB-10A/U FOR ORAL/ENT USE
K862865 · Directed Energy, Inc. · Jan 1987
MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT)
K862150 · Directed Energy, Inc. · Sep 1986
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · Laserscope · Aug 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875 · Endo Lase, Inc. · Jan 1986