Cleared Traditional

K854471 - PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T

K854471 is an FDA 510(k) clearance for PORTALASE 300 CARBON DIOXIDE SURG LASER..., manufactured by Minnesota Laser Corp.. The device is a Class 2 Ear, Nose, Throat device with product code EWG cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K854471 · Minnesota Laser Corp. · Ear, Nose, Throat device
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Feb 1986
Decision
99d
Days
Class 2
Risk

K854471 is an FDA 510(k) clearance for the PORTALASE 300 CARBON DIOXIDE SURG LASER EAR/NOSE/T. Classified as Laser, Ent Microsurgical Carbon-dioxide (product code EWG), Class II - Special Controls.

Submitted by Minnesota Laser Corp. (Minneapolis, US). The FDA issued a Cleared decision on February 13, 1986 after a review of 99 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 Minnesota Laser Corp. devices

FDA 510(k) Submission Details - K854471

510(k) Number K854471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1985
Decision Date February 13, 1986
Days to Decision 99 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
9d slower than avg
Panel avg: 90d · This submission: 99d
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 16
Devices cleared under the same product code (EWG) and FDA review panel - the closest regulatory comparables to K854471.
LASERSCOPE OMNIPLUS PHOTOSURGICAL SYSTEM/CO2 LASER
K862005 · Laserscope · Aug 1986
MODEL 545-45 LASER FOR EAR, NOSE & THROAT
K860975 · Britt Corp., Inc. · Jul 1986
MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT
K860277 · Britt Corp., Inc. · May 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
LASER GAS MIXTURES
K820535 · Union Carbide Corp. · Mar 1982