Cleared Traditional

K855146 - LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL

K855146 is an FDA 510(k) clearance for LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/..., manufactured by Laserscope. The device is a Class 2 Ear, Nose, Throat device with product code LMS cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K855146 · Laserscope · Ear, Nose, Throat device
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Apr 1986
Decision
108d
Days
Class 2
Risk

K855146 is an FDA 510(k) clearance for the LASERSCOPE OMNIPLUS PHOTOSURGICAL SYST/ND:YAG OTOL. Classified as Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology (product code LMS), Class II - Special Controls.

Submitted by Laserscope (Santa Clara, US). The FDA issued a Cleared decision on April 11, 1986 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4490 - 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.

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FDA 510(k) Submission Details - K855146

510(k) Number K855146 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1985
Decision Date April 11, 1986
Days to Decision 108 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
18d slower than avg
Panel avg: 90d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LMS Device Classification - Class 2, Special Controls

Product Code LMS Laser, Microsurgical Argon, For Uses Other Than Otology, Including Laryngology & General Use In Otolaryngology
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4490
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.