MedX Oralase Console System

The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device which provides low level laser therapy…

Registry build 21.09.26

The MedX Oralase Console system is a therapeutic Low-Level Laser and Light therapy system for Oralase application. It features a handheld laser device which provides low level laser therapy to a smaller focused treatment area. The single near-infra-red laser diode tip has a visible LED guide light and can be used with either the intra-oral or extra-oral light guides. The MedX 1100N console powers the handheld laser therapy device and also two SLD accessories. The MedX SLD Light cluster accessory offers light therapy for broader treatment applications. This accessory can be strapped to the body for “hands-free” unattended treatment.

235manufacturers in China registered for this device type
1catalogue number

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 MedX Oralase Console System
Listed by MedX Health Corp., Canada
FDA product code ILY
Device type Lamp, Infrared, Therapeutic Heating
Device class Class 2
Regulation 21 CFR 890.5500
Establishment Manufacturer
Record published 2017-12-22
Record revised 2022-12-08 (version 7)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Supplied as a kit Yes
Label carries serial number
Storage Storage environment temperature -4 to 149 °F; Handling environment humidity 20 to 95 % RH; Handling environment temperature 32 to 104 °F
Packaging Shipping carton box of 5, shipping carton box of 3, shipping carton box of 2

Catalogue Numbers

Catalogue numbers for MedX Oralase Console System
Catalogue number Size Status
3120 In distribution

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