Cleared Traditional

K911150 - SOREX SAFE-AIR

K911150 is the FDA 510(k) clearance for SOREX SAFE-AIR by Sorex Medical. It is a Class 2 General & Plastic Surgery device (product code GEX) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K911150 · Sorex Medical · General & Plastic Surgery device
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Jun 1991
Decision
105d
Days
Class 2
Risk

K911150 is an FDA 510(k) clearance for the SOREX SAFE-AIR. Classified as Powered Laser Surgical Instrument within the GEX classification (a category for powered laser surgical instruments across multiple specialties), Class II - Special Controls.

Submitted by Sorex Medical (Salt Lake City, US). The FDA issued a Cleared decision on June 28, 1991 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Sorex Medical devices

Submission Details

510(k) Number K911150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1991
Decision Date June 28, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEX Powered Laser Surgical Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. Typically Indicated To To Cut, Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue, For General Surgical Purpose In Medical Specialties Of General And Plastic Surgery, Dermatology/aesthetic, Podiatry, Otolaryngology (ent), Gynecology, Neurosurgery, Orthopedics (soft Tissue), Dental And Oral Surgery, And Dentistry. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEX Powered Laser Surgical Instrument

All 737
Devices cleared under the same product code (GEX) and FDA review panel - the closest regulatory comparables to K911150.
NIDEK MODELS AC-2100 & 2200
K913465 · Nidek, Inc. · Oct 1991
SHARPLAN SHARPLASE FAMILY ND:YAG SCULPTED FIBERS
K913037 · Sharplan Lasers, Inc. · Sep 1991
SHARPLAN ND:YAG SURG.LASER,MODEL 3040 SHARPLASER
K912792 · Sharplan Lasers, Inc. · Aug 1991
SHARPLAN ND:YAG SURG LASER, 3065, SHARPLASER 65
K910051 · Sharplan Lasers, Inc. · Apr 1991
NIDEK DC-3000 DIODE LASER PHOTOCOAGULATOR
K903639 · Nidek, Inc. · Feb 1991
NIDEK INC. MODEL AC-2000 DERM
K904402 · Nidek, Inc. · Dec 1990