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.

Theralase · Powered Light Based Laser Non-Thermal Instrument with Non-Heating Effect for Adjunctive Use in Pain Therapy → Physical Medicine

Name: Theralase
Brand: Theralase

5manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

7recalls on this 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 Theralase
Listed by	Theralase Technologies Inc., Canada
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)	K151816
Record published	2023-12-14

Specifications

Specifications
MRI safety	MR Safe
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Theralase
Catalogue number	Size	Status
TLC-1000		In distribution
TLC-2000		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
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
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
K151816	2015-11-19
K050342	2005-07-11

Recalls Naming This Product

7 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Theralase
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Process control	Device was shipped without a Unique Device Identification (UDI) label.	41 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Process control	Device was shipped without a Unique Device Identification (UDI) label and a separate label identifies the power pack as CE Marked when the device has not yet received the CE Mark.	306 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Process control	Laser Probe (Model Number: TLC-2001) Electromagnetic Interference ( EMI ) in excess of IEC-60601-1-2 (4th edition) standard	18 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Process control	Power supply (Model Number: TLC-2003) ME90A2403F01 (24 VDC, 3.75 A, 90 W, 1% peak to peak ripple and noise, which meets UL/EN/IEC-60601-1-2, 4th edition specification) shipped versus Power supply (Model Number: TLC-2003) MENB1100A2403F01 (2	76 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Process control	Power Pack (component) was shipped with an internal battery pack tested to UN-38.3, UL-2054 and IEC-62133 (2nd Edition) standards; however, not tested to IEC-60601-1-2 (3rd edition) standards	202 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Device Design	660 nm laser diodes may be below rated power output.	92 units	2020-12-03
Theralase Technologies Inc.	510(k) number	2019-09-26	Class III	Device Design	905 nm laser diodes may be below rated power output.	92 units	2020-06-04

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.

Theralase