BEUDAMED
    Product Code: NHN FDA class 2 21 CFR 890.5500

    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

    Physical Medicine

    The Powered Light Based Laser Non-Thermal Instrument With Non-Heating Photon Energy (product code NHN) is a physical medicine device that uses low-level laser or light energy in a non-thermal manner to deliver photon energy to tissue for therapeutic effects, as described in its definition. It is classified as an FDA Class 2 device within the Physical Medicine specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    54
    FEI Numbers
    20
    Registration Numbers
    20
    Unique Applicants
    31
    Years Active
    24

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    Basic Information

    Product Code
    NHN
    Device Class
    FDA class 2
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Review Panel
    PM
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 54 510(k) clearances via K numbers.

    K Number Device Name
    K254024 MR5 Activ Pro
    K251903 Erchonia DPN Laser (Model# EVRL)
    K252273 Therapy US
    K241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)
    K232813 Therapy EC, Therapy XT
    K231409 Erchonia FX-405
    K212189 FibroLux
    K221987 Erchonia GVL
    K203337 PainTB, PainTJ
    K212595 Erchonia FX-405
    K211186 Erchonia XLR8
    K191257 Erchonia EVRL
    K190572 Erchonia FX-635
    K180197 Erchonia FX-635
    K180585 Collagentex Rx-6
    K171354 MR4 Laser
    K162022 Collagentex Rx-1
    K152196 Erchonia EVRL
    K153052 Erchonia PL Touch
    K151816 TLC-2000 Therapeutic Medical Laser System
    K132940 ERCHONIA ALLAY
    K130996 ERCHONIA EMERGE
    K130741 ERCHONIA PL5000
    K101430 MLS-AC DERMA SCANNER
    K100509 THL1 LASER
    K081166 LIGHTSTREAM LOW LEVEL LASER
    K080513 QLASER SYSTEM
    K073689 LEP2000 THERAPY SYSTEM
    K072206 ERCHONIA EML LASER
    K072551 LD-I 75 AND LD-I 200
    K063574 LUMINEX LL LASER SYSTEM
    K053507 ELITE ELECTROMED L.I.T.E. 4/1
    K050668 GRT LITE, MODEL 8-A
    K051631 EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001
    K050342 THERALASE TLC-1000 THERAPEUTIC MEDICAL LASER SYSTEM
    K043353 OMEGA EXCEL/XP LASER SYSTEM
    K041565 LAZRPULSR 4X
    K034009 LAPEX 2000
    K041530 EXCALIBUR LIGHT THERAPY SYSTEM, MODEL SGIEX-04-001
    K041139 ERCHONIA EML LASER
    K032816 QUANTUM LIGHT THERAPY SYSTEM
    K023060 ACCULASER PRO4
    K032216 BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM
    K033015 AXIOM BIOLASER LLLT SERIES-3
    K031499 DIOBEAM 830
    K030622 AXIOM BIOLASER LLLT SERIES-1
    K030692 POWER LASER 90
    K024310 NMA 1052 CONSOLE SYSTEM WITH NMA 100 LASER ACCESSORY
    K030226 THOR DDII 830CL3 LASER SYSTEM
    K023935 TRILUMINA THERAPEUTIC LASER SYSTEM
    K021985 MEDX LCS LASER SERIES
    K020657 ACCULASER PRO LOW LEVEL LASER THERAPY DEVICE
    K010175 MICROLIGHT 830 LASER SYSTEM
    K012580 ERCHONIA PL2000

    FEI Numbers

    This FDA classification entry is associated with 20 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 20 registration numbers. Click on an entry to view related FDA registrations.