Cleared Traditional

K033015 - AXIOM BIOLASER LLLT SERIES-3

K033015 is an FDA 510(k) clearance for AXIOM BIOLASER LLLT SERIES-3, 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 60-day FDA review.

K033015 · Axiom Usa., Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
60d
Days
Class 2
Risk

K033015 is an FDA 510(k) clearance for the AXIOM BIOLASER LLLT SERIES-3. 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 November 25, 2003 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K033015

510(k) Number K033015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date November 25, 2003
Days to Decision 60 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
56d faster than avg
Panel avg: 116d · This submission: 60d
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 K033015.
QUANTUM LIGHT THERAPY SYSTEM
K032816 · Stargate International, Inc. · Mar 2004
ACCULASER PRO4
K023060 · Acculaser, Inc. · Mar 2004
BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
K032216 · Bioptron AG · Feb 2004
DIOBEAM 830
K031499 · Soft-Core Texas, Inc. · Sep 2003
AXIOM BIOLASER LLLT SERIES-1
K030622 · Axiom Usa., Inc. · Sep 2003
POWER LASER 90
K030692 · Andi Electromedical Aps · Jul 2003
K033015 · AXIOM BIOLASER LLLT SERIES-3
Download PDF FDA Summary Axiom Usa., Inc.