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

Product Code: NHN

Physical Medicine Medical Laser Products

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

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005] Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 890.5500


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as NHN

5228Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain TherapyInfrared Lamp.

Total Product Life Cycle (TPLC) Devices

5228Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain TherapyInfrared Lamp.

FDA Consensus Standards

Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy [29958]21 CFR §890.5500 🔎

Pre-market Notifications for NHN

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K191257Erchonia EVRLErchonia Corporation
K190572Erchonia FX-635Erchonia Corporation
K180585Collagentex Rx-6Tanses Technologies Inc.
K180197Erchonia FX-635Erchonia Corporation
K171354MR4 LaserMulti Radiance Medical
K162022Collagentex Rx-1Tanses Technologies Inc.
K153052Erchonia PL TouchERCHONIA CORPORATION
K152196Erchonia EVRLERCHONIA CORPORATION
K151816TLC-2000 Therapeutic Medical Laser SystemTheralase Inc.
K132940ERCHONIA ALLAYERCHONIA MEDICAL, INC.

Global Unique Device Identification Database

00869340000305Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006336Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006312Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006299Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006282Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006268Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006237Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006213Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006206Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006190Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006183Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006176Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006152Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006145Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
00859626006138Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Maude Adverse Events

TRISTAR ONE- PHOTONS SYSTEMTRISTAR ONE2019-07-31
635 NANOMETER LIGHT (NHN)ERCHONIA (ERCHMEDIC)2010-06-23

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