What is FDA product code NHN?

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.

Physical Medicine › TherapeuticPowered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

XLR8

Name: XLR8
Brand: XLR8

MEDICAL - Handheld Low Level Laser - 2 diodes - 640nm 10mW - includes induction charger

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

17510(k) clearances naming this product code

Who Else Makes It

Concentrated in Hubei (4), Guangdong (1).

Chinese manufacturers registered for FDA product code NHN
Manufacturer	City	Province	Registered as	Device types
Hubei YJT Intelligent Technology Group Co., Ltd.	Wuhan	Hubei	Contract manufacturer	12
Rhein Laser Technologies Co., Ltd.	Wuhan	Hubei	Complaint-file establishment	6
Wuhan Lotuxs Technology Co., Ltd.	Wuhan	Hubei	Complaint-file establishment	5
Wuhan Guangdun Technology Co., Ltd.	Wuhan	Hubei	Manufacturer	2
Seic Shenzhen Shinelong Electronics Industrial Co.	Long Gang District,, Shenzhen	Guangdong	Contract manufacturer	1

Record

Regulatory record for XLR8
Listed by	Erchonia Corporation, United States
FDA product code	NHN
Device type	Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Device class	Class 2
Regulation	21 CFR 890.5500
Establishment	Remanufacturer, Complaint-file establishment, Manufacturer
510(k)	K211186
Record published	2016-09-24
Record revised	2022-12-08 (version 8)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for XLR8
Catalogue number	Size	Status
HLS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
ML 830®	Microlight Corporation OF America	24
LEP 2000 Photonic Therapy System	IMI Healing Technologies Inc	6
FX635	Erchonia Corporation	2
Theralase	Theralase Technologies Inc.	2
Collagentex Series	Tanses Technologies, Inc.	2
Laspot	Wuhan Guangdun Technology Co., Ltd.	1
EVL	Erchonia Corporation	1
PL Touch	Erchonia Corporation	1
Erchonia GVL	Erchonia Corporation	1
Therapy XT (FDA)	DMC Importacao E Exportacao DE Equipamentos Ltda	1
GlobTek	Microlight Corporation OF America	1
Therapy US (FDA)	DMC Importacao E Exportacao DE Equipamentos Ltda	1

Showing 12 of 18. All products under Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K251903	2026-02-19
K231409	2023-08-11
K221987	2022-09-01
K212595	2021-11-12
K211186	2021-10-22
K191257	2019-08-08
K190572	2019-06-01
K180197	2018-05-21
K152196	2016-02-18
K153052	2016-01-04
K132940	2014-04-14
K130996	2013-09-16
K130741	2013-04-23
K101430	2010-06-22
K100509	2010-06-08
K072206	2008-04-24
K041139	2004-09-30

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.