Platinum

Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain,…

Registry build 21.09.26

Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave – CW power 28W and Intense Super Pulse – ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.

235manufacturers in China registered for this device type
9catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (145), Zhejiang (21), Jiangsu (9). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ILY
Manufacturer City Province Registered as Device types
Zhongshan Chukuang Textile Co., Ltd. Zhongshan Guangdong Contract manufacturer 26
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Shenzhen Kaiyan Medical Equipment Co., Ltd. Shenzhen Guangdong Contract manufacturer 17
ATL Technology DG,Ltd. Dongguan Guangdong Contract manufacturer 14
Dongguan Tutamen Metalwork Co., Ltd. Dongguan Guangdong Contract manufacturer 12
Gymmax Technology Shenzhen Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Xuzhou Kernel Medical Equipment Co Ltd Xuzhou Jiangsu Contract manufacturer 7
Hangzhou Wellbeing Technology Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Wuxi Jiajian Medical Instrument Co., Ltd. Wuxi Jiangsu Contract manufacturer 6
Shenzhen Sungpo HI-Tech Electronic Co., Ltd. Shenzhen Guangdong Contract manufacturer 6
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. Shenzhen Guangdong Contract manufacturer 4
Shenzhen Allbeauty Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 4

Showing 12 of 235. All 235 manufacturers in China registered for Lamp, Infrared, Therapeutic Heating

Record

Regulatory record for Platinum
Listed by Summus Medical Laser, LLC, United States
FDA product code ILY
Device type Lamp, Infrared, Therapeutic Heating
Device class Class 2
Regulation 21 CFR 890.5500
Establishment Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-08-16
Record revised 2024-07-23 (version 55)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number
Storage Handling environment atmospheric pressure 86 to 106 KiloPascal; Handling environment humidity 30 to 75 % RH; Storage environment humidity 0 to 80 % RH; Handling environment temperature 10 to 35 °C; Storage environment temperature 0 to 35 °C
Distribution end date 2019-07-20

Catalogue Numbers

Catalogue numbers for Platinum
Catalogue number Size Status
P4H In distribution
SLH1 In distribution
SLP1 In distribution
KP1 In distribution
SLP4 In distribution
SLP3 In distribution
KP3 Withdrawn
KP4 Withdrawn
KGH1 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Lescolton Shenzhen Lescolton Medical Equipment Co., Ltd. 50
HealthLight Healthlight LLC 40
Therapy Light E.shine Lighting Co., Limited 32
Phoenix Thera-Lase system Phoenix Thera-Lase Systems, LLC 32
AisQueen Shenzhen AIS Queen Medical Technology Co., Ltd. 30
LED RED Light Therapy Panel Shenzhen RedV Medical Equipment Co., Ltd. 27
Chattanooga DJO, LLC 25
Lumix Ultra/Plus Fisioline SRL 22
UTK UTK Technology(Shenzhen)Limited 21
LZ30 Avant Wellness Systems Inc 21
LS Pro Systems Wellness Without Limits LLC 21
Dimed Wuhan Dimed Laser Technology Co., Ltd. 20

Showing 12 of 536. All products under Lamp, Infrared, Therapeutic Heating

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer