Icoone Laser

Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with…

Registry build 21.09.26

Icoone Laser (also referred to as Icoone Beauty Laser) is Therapeutic Massager machine attached to pivoting wheels, connected to a rolling stand, with a series of hand pieces equipped with motorized rollers, which are the core of the technology and that, opportunely guided by an operator, are applied to the patient’s body. The combined synergistic action between the micro-stimulators (rollers) and a negative pressure (vacuum) created within the hand pieces grasp the skin tissues allowing to achieve the same effects of kneading and stroking tissue by hand. Icoone Medical Laser (model ref 610BEC04) (also referred to as Icoone Laser med) is also equipped with two light sources inside the Robosolo hand piece, each with the following wave lengths: – Led @ 650nm (50mW) – Laser @ 915nm (10mW) The light is emitted via laser diodes or LEDs controlled by a dedicated power driver.

437manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (213), Zhejiang (102), Fujian (43). 45 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ISA
Manufacturer City Province Registered as Device types
Hospital & Homecare IMP. & EXP. Co., Ltd. Nanjing Jiangsu Contract manufacturer 179
Ningbo Castle Medical Import & Export Co., Ltd. Ningbo Zhejiang Contract manufacturer 67
Foshan Hongfeng Co., Ltd. Foshan Guangdong Contract manufacturer 24
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Guangzhou Xinbo Electronic Co., Ltd. Guangzhou Guangdong Contract manufacturer 18
Ningbo Albert Novosino Co., Ltd. Yuyao Zhejiang Contract manufacturer 17
Beilun Plastech Inc Ningbo Zhejiang Contract manufacturer 13
Shenzhen Roundwhale Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 8
Zhangzhou Easepal Innovation Co., Ltd. Zhangzhou Fujian Contract manufacturer 7
Shenzhen Xiangzhida Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 7
Jiangsu Alphay Medical Device Co., Ltd. Nantong Jiangsu Contract manufacturer 6
Taizhou Rapson Glasses Co., Ltd. Linhai Zhejiang Contract manufacturer 6

Showing 12 of 437. All 437 manufacturers in China registered for Massager, Therapeutic, Electric

Record

Regulatory record for Icoone Laser
Listed by I-Tech Industries SRL, Italy
FDA product code ISA
Device type Massager, Therapeutic, Electric
Device class Class 1
Regulation 21 CFR 890.5660
Establishment Manufacturer, Exporter
510(k) K211272
Record published 2023-11-30
Record revised 2024-06-06 (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 temperature 10 to 30 °C; Handling environment atmospheric pressure 30 to 106 KiloPascal; Handling environment humidity 10 to 75 % RH
Sizes Pressure 20 KiloPascal

Catalogue Numbers

Catalogue numbers for Icoone Laser
Catalogue number Size Status
Icoone Laser (also referred to as Icoone beauty laser) Pressure 20 KiloPascal In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Human Touch Human Touch, LLC. 190
Homedics Health Care Massage Branch of Zhangzhou Easepal Industrial Corporation 102
Conair Conair LLC. 87
Sharper Image Merchsource LLC 62
Renpho Joicom Corporation 59
3H 3H Co., Ltd. 48
silverfox Silverfox Corporation Limited 35
Thermage Solta Medical, Inc. 35
Renpho Eye Massager Joicom Corporation 32
Homedics Smart Home Branch of Zhangzhou Easepal Industrial Corporation 28
G5® General Physiotherapy, Inc. 26
Homedics Zhangzhou Easepal Innovation Co., Ltd. 23

Showing 12 of 249. All products under Massager, Therapeutic, Electric

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