510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NHNClass II

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

21 CFR 890.5500 / Physical Medicine
FDA source (opens on fda.gov)

NHN is the FDA product code for Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy, a class II device type, regulated under 21 CFR 890.5500. FDA's definition for this code reads: "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...". As of , FDA records hold 54 510(k) clearances under this code, the most recent dated , and 7 recalls.

Classification record

Product code
NHN
Device name
Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
FDA 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.
Regulation
21 CFR 890.5500
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
54
Ingested recalls
7

Clearances, product code NHN

By decision year
54 clearances under product code NHN with a decision year between 2002 and 2026, 2003 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code NHN by decision year
YearClearances
20024
20037
20045
20055
20062
20071
20083
20092
20102
20132
20141
20151
20163
20183
20192
20212
20223
20231
20241
20252
20262

Applicants with the most clearances

Product code NHN
Applicants holding the most 510(k) clearances under product code NHN
ApplicantClearances
Erchonia Corporation12
Erchonia Medical, Inc.5
Multi Radiance Medical3
Stargate International, Inc.3
Acculaser, Inc.2
Axiom USA., Inc.2
DMC Importacao e Exportacao de Equipamentos Ltda2
Medx Electronics, Inc.2
Tanses Technologies, Inc.2
Theralase Technologies Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order