Cleared Traditional

K810740 - ARGON MICROSURIGAL PROTOCOLS

K810740 is an FDA 510(k) clearance for ARGON MICROSURIGAL PROTOCOLS, manufactured by Lumenis, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K810740 · Lumenis, Inc. · Ear, Nose, Throat device
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Aug 1981
Decision
155d
Days
Class 2
Risk

K810740 is an FDA 510(k) clearance for the ARGON MICROSURIGAL PROTOCOLS. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Lumenis, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 21, 1981 after a review of 155 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 Lumenis, Inc. devices

FDA 510(k) Submission Details - K810740

510(k) Number K810740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1981
Decision Date August 21, 1981
Days to Decision 155 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
66d slower than avg
Panel avg: 89d · This submission: 155d
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.