Elite Iq PRO

The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs…

Registry build 21.09.26

The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completiomn of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider wine and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of psuedo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the competition of a treatment regime. The Skintel Reader is intended as an onbjective measurement tool for examing skin melanin content for determing and setting a test spot starting fluence.

92manufacturers in China registered for this device type
1catalogue number

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 PRO
Listed by Deka M.e.l.a. SRL
FDA product code GEX
Device type Powered Laser Surgical Instrument
Device class Class 2
Regulation 21 CFR 878.4810
510(k) K240396
Record published 2024-03-13

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 PRO
Catalogue number Size Status
M122K1 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