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.

ML 830® · Powered Light Based Laser Non-Thermal Instrument with Non-Heating Effect for Adjunctive Use in Pain Therapy → Physical Medicine

Name: ML 830®
Brand: ML 830®

5manufacturers in China registered for this device type

24catalogue numbers in this listing

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 ML 830®
Listed by	Microlight Corporation OF America, 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	Specification developer, Manufacturer
510(k)	K010175
Record published	2016-08-15
Record revised	2022-12-08 (version 5)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Over the counter	Yes
Supplied as a kit	Yes
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for ML 830®
Catalogue number	Per pack	Status
ML-830-01-007		In distribution
ML-830-02-011		In distribution
ML-830-02-005		In distribution
ML-830-07-003		In distribution
ML-830-04-000		In distribution
ML-830-07-100		In distribution
ML-830-04-002		In distribution
ML-830-04-003		In distribution
ML-830-07-007		In distribution
ML-830-02-003		In distribution
ML-830-07-004		In distribution
ML-830-02-007		In distribution
ML-830-02-000		In distribution
ML-830-01-003		In distribution
ML-830-01-000		In distribution
ML-830-01-002		In distribution
ML-830-02-006		In distribution
ML-830-04-009		In distribution
ML-830-01-004		In distribution
ML-830-01-005	10	In distribution
ML-830-07-001		In distribution
ML-830-02-010		In distribution
ML-830-01-001		In distribution
ML-830-01-009		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
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
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
K010175	2002-02-06

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.

ML 830®