Cleared Traditional

K862150 - MODEL 8-B WITH OS-1 ATTACHMENT (C02 LAS...

K862150 is an FDA 510(k) clearance for MODEL 8-B WITH OS-1 ATTACHMENT (C02 LAS..., 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 92-day FDA review.

K862150 · Directed Energy, Inc. · Ear, Nose, Throat device
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Sep 1986
Decision
92d
Days
Class 2
Risk

K862150 is an FDA 510(k) clearance for the MODEL 8-B WITH OS-1 ATTACHMENT (C02 LASER FOR ENT). 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 September 4, 1986 after a review of 92 days - within the typical 510(k) review window.

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 - K862150

510(k) Number K862150 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 04, 1986
Decision Date September 04, 1986
Days to Decision 92 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
3d slower than avg
Panel avg: 89d · This submission: 92d
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 K862150.
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 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866 · Directed Energy, Inc. · Jan 1987
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · Laserscope · Aug 1986
ENDO-LASE CD-100 CO2 LASER FOR OTORHINOLARYNGOLOGY
K853875 · Endo Lase, Inc. · Jan 1986
ENDO-LASE CD40 FOR OTORHINOLARYNGOLOGY
K853902 · Endo Lase, Inc. · Jan 1986