Ipl Therapy Machine

VE2000 is an intense pulsed light system for aesthetic and surgical applications involving hair reduction and benign pigmented or vascular lesions. A handpiece delivers broad-spectrum light…

Registry build 21.09.26

VE2000 is an intense pulsed light system for aesthetic and surgical applications involving hair reduction and benign pigmented or vascular lesions. A handpiece delivers broad-spectrum light to the skin.

The system produces light from 480 nm to 1200 nm. Treatment uses selective photothermolysis, in which selected light pulses heat target chromophores; wavelength and pulse settings form part of the treatment selection.

Hair Reduction

Its hair indication is permanent hair reduction, defined as a stable long-term decrease in regrowing hairs measured at 6, 9 and 12 months after a treatment regimen. The appropriate treatment configuration depends on the intended application.

31manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangdong (11), Beijing (10), Hebei (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ONF
Manufacturer City Province Registered as Device types
Xiamen Solex High-Tech Industries Co., Ltd. Xiamen Fujian Contract manufacturer 9
Shen Zhen HanShine Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 5
VTech Communications Ltd Dongguan Guangdong Contract manufacturer 5
Beijing Starlight Science & Technology Development Co., Ltd. Beijing Beijing Contract manufacturer 4
Guangzhou Telefield Limited Guangzhou Guangdong Contract manufacturer 3
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. Shenzhen Guangdong Manufacturer 17
Beijing Winkonlaser Technology Limited Beijing Beijing Contract manufacturer 14
Beijing Beautemax Technology Limited Beijing Beijing Contract manufacturer 13
Guangdong Fuqiang Beauty Equipment Co., Limited Qingyuan Guangdong Manufacturer 13
Shenzhen Perfect Idea Technology Limited Shenzhen Guangdong Contract manufacturer 10
Beijing Adss Development Co., Ltd. Beijing Beijing Manufacturer 8
Rejuva Fresh LLC Shenzhen Guangdong Manufacturer 6

Showing 12 of 31. All 31 manufacturers in China registered for Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Record

Regulatory record for Ipl Therapy Machine
Listed by Beijing Adss Development Co., Ltd., China
FDA product code ONF
Device type Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Device class Class 2
Regulation 21 CFR 878.4810
Establishment Manufacturer
510(k) K161286
Record published 2018-04-09
Record revised 2022-08-31 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Ipl Therapy Machine
Catalogue number Size Status
VE2000 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Isolaz Solta Medical, Inc. 21
Quantaforte Quanta System Spa 8
Apolomed Shanghai Apolo Medical Technology Co., Ltd. 7
Me Iluminage Ltd 7
Remington Spectrum Brands, Inc. 6
Silk’n Home Skinovations, Ltd. 6
Huamei Shandong Huamei Technology Co., Ltd. 6
Remington Products Spectrum Brands, Inc. 6
Intense Pulsed Light (IPL) System Shenzhen Fansizhe Science AND Technology Co., Ltd. 5
Iluminage Iluminage Ltd 5
Luma Rx Spectrum Brands, Inc. 5
Silk’n Silkn Beauty Ltd. 4

Showing 12 of 133. All products under Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K233307 2024-03-15
K161286 2016-08-04

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