Cleared Traditional

K841860 - CO2 SURGICAL LASER SYSTEM XML-10

K841860 is an FDA 510(k) clearance for CO2 SURGICAL LASER SYSTEM XML-10, manufactured by Xanar, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K841860 · Xanar, Inc. · Ear, Nose, Throat device
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Nov 1984
Decision
188d
Days
Class 2
Risk

K841860 is an FDA 510(k) clearance for the CO2 SURGICAL LASER SYSTEM XML-10. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Xanar, Inc. (Colorado Springs, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 188 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 Xanar, Inc. devices

FDA 510(k) Submission Details - K841860

510(k) Number K841860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1984
Decision Date November 08, 1984
Days to Decision 188 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
99d slower than avg
Panel avg: 89d · This submission: 188d
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 12
Devices cleared under the same product code (EWG) and FDA review panel - the closest regulatory comparables to K841860.
MODEL 10-C W/LP-10A/U & OS-10A/U FOR ORAL/ENT USE
K862866 · 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
LASER GAS MIXTURES
K820535 · Union Carbide Corp. · Mar 1982
ARGON MICROSURIGAL PROTOCOLS
K810740 · Lumenis, Inc. · Aug 1981