Elite Iq

The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and…

Registry build 21.09.26

The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase (M122D1 model). The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

92manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Beijing (28), Guangdong (21), Hebei (13). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEX
Manufacturer City Province Registered as Device types
Jabil Circuit (Shanghai) Ltd. Shanghai Shanghai Contract manufacturer 31
Sanbor Medical Xiamen, Inc. Xiamen Fujian Contract manufacturer 16
Beijing Winkonlaser Technology Limited Beijing Beijing Contract manufacturer 14
Changsha Gomecy Electronics Co., Ltd. Changsha Hunan Contract manufacturer 9
Gymmax Technology Shenzhen Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Guangzhou Niansheng Beauty Equipment Co., Ltd. Guangzhou Guangdong Contract manufacturer 7
Beijing Syntech Laser Co., Ltd. Beijing Beijing Contract manufacturer 5
VTech Communications Ltd Dongguan Guangdong Contract manufacturer 5
Wuhan Dimed Laser Technology Co., Ltd. Wuhan Hubei Contract manufacturer 3
Chengdu Vantron Technology Co., Ltd. Chengdu Sichuan Contract manufacturer 1
Shanghai Shengguang Science & Technology Co., Ltd. Shanghai Shanghai Contract manufacturer 1
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25

Showing 12 of 92. All 92 manufacturers in China registered for Powered Laser Surgical Instrument

Record

Regulatory record for Elite iQ
Listed by El.en. SPA
FDA product code GEX
Device type Powered Laser Surgical Instrument
Device class Class 2
Regulation 21 CFR 878.4810
510(k) K193426
Record published 2020-03-13
Record revised 2023-02-03 (version 2)

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 70 to 106 KiloPascal; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment humidity 20 to 80 % RH; Handling environment temperature 10 to 27 °C; Storage environment humidity 10 to 90 % RH; Storage environment temperature 5 to 50 °C

Catalogue Numbers

Catalogue numbers for Elite iQ
Catalogue number Size Status
M122B1 In distribution
M122D1 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Accu-Beam Transamerican Technologies International 181
Powered Laser Surgical Instrument Weinert Fiber Optics Inc. 117
Waterlase Laser Tips Biolase Technology, Inc. 112
ProFlex™ Innovaquartz LLC 109
Dornier MedTech Dornier Medtech America, Inc. 91
Powered Laser Surgical Instrument Ophthalmed LLC 90
Optilite Convergent Laser Technologies 87
Reusable Surgical Optical Fiber Quanta System Spa 78
Single use Surgical Optical Fiber Quanta System Spa 70
Powered Laser Surgical Instrument Lutronic Corporation 57
Waterlase iPlus Dental Laser System Biolase Technology, Inc. 53
Leoni™ Weinert Fiber Optics Inc. 49

Showing 12 of 2,654. All products under Powered Laser Surgical Instrument

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