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

Therapy XT (FDA)

Name: Therapy XT (FDA)
Brand: Therapy XT (FDA)

Therapy XT delivers non-heating infrared laser light as an adjunct for temporary relief of hand and wrist pain associated with carpal tunnel syndrome. It is intended for healthcare…

Registry build 21.09.26

Therapy XT delivers non-heating infrared laser light as an adjunct for temporary relief of hand and wrist pain associated with carpal tunnel syndrome. It is intended for healthcare professionals such as physicians, nurses and physical therapists.

An 808 nm semiconductor laser diode generates the light, with optical output controlled by the electrical current supplied to the diode. Optical fibers carry the emitted light toward the treatment tip. The system includes a handpiece, battery and charging cable.

Patient Contact

A polycarbonate spacer maintains the distance between the tip and the skin. The spacer is the only component that touches the patient. The system also includes a handpiece holder, protective eyewear and a transport case.

5manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

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 Therapy XT (FDA)
Listed by	DMC Importacao E Exportacao DE Equipamentos Ltda, Brazil
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	Manufacturer
510(k)	K232813
Record published	2025-01-21

Specifications

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

Catalogue Numbers

Catalogue numbers for Therapy XT (FDA)
Catalogue number	Size	Status
230020094		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
GlobTek	Microlight Corporation OF America	1
Therapy US (FDA)	DMC Importacao E Exportacao DE Equipamentos Ltda	1
FibroLux	Multi Radiance Medical, Inc.	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
K232813	2024-12-19

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.