Cleared Traditional

K030622 - AXIOM BIOLASER LLLT SERIES-1

K030622 is an FDA 510(k) clearance for AXIOM BIOLASER LLLT SERIES-1, manufactured by Axiom Usa., Inc.. The device is a Class 2 Physical Medicine device with product code NHN cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K030622 · Axiom Usa., Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
194d
Days
Class 2
Risk

K030622 is an FDA 510(k) clearance for the AXIOM BIOLASER LLLT SERIES-1. Classified as Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy (product code NHN), Class II - Special Controls.

Submitted by Axiom Usa., Inc. (Tampa, US). The FDA issued a Cleared decision on September 9, 2003 after a review of 194 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K030622

510(k) Number K030622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2003
Decision Date September 09, 2003
Days to Decision 194 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d slower than avg
Panel avg: 116d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NHN Device Classification - Class 2, Special Controls

Product Code NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. This Device Emits Energy In The Infrared Or Other Wavelengths, Provides Non-heating And Non-thermal Effect, And Is Indicated For Adjunctive Use In Pain Therapy Or Related Indication. It Does Not Provide Therapeutic Topical Heating. The Classification Regulation For Infrared Lamps Describes A Device That Emits Energy In The Infrared Wavelength To Provide Topical Heating And That Is Not Limited To Adjunctive Use.
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - NHN Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy

All 53
Devices cleared under the same product code (NHN) and FDA review panel - the closest regulatory comparables to K030622.
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K024310 · Medx Electronics, Inc. · Mar 2003
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K030226 · Thor Intl. · Feb 2003
K030622 · AXIOM BIOLASER LLLT SERIES-1
Download PDF FDA Summary Axiom Usa., Inc.