What is FDA product code GEI?

Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

General & Plastic Surgery › SurgicalElectrosurgical, Cutting & Coagulation & Accessories

Radio Frequency System

Name: Radio Frequency System
Brand: Radio Frequency System

The Radio Frequency System provides electrocoagulation and haemostasis in dermatological and general surgical procedures. It delivers bipolar RF energy through a treatment handpiece fitted…

Registry build 21.09.26

The Radio Frequency System provides electrocoagulation and haemostasis in dermatological and general surgical procedures. It delivers bipolar RF energy through a treatment handpiece fitted with either microneedle electrodes or nonpenetrating RF electrodes.

The touchscreen sets output power, duration and needle depth and displays treatment information. Microneedles enter the epidermis, while the nonpenetrating electrodes remain at the surface. Energy produces local heating around the uninsulated electrode area to coagulate tissue.

System Arrangement

The system includes a host unit, mobile base, handpiece and pedal switch. The operator holds the handpiece perpendicular to the tissue and selects the settings for the intended electrode configuration.

65manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (24), Zhejiang (13), Shanghai (10). 23 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code GEI
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Hangzhou Kangji Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	27
Modern Medical Equipment Manufacturing Ltd.	Heng Li, Dongguan	Guangdong	Contract manufacturer	26
Amphenol Alden Products Company	Shenzhen	Guangdong	Contract manufacturer	24
Hangzhou Endo Medical Instrument Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	19
Hong Qiangxing (Shen Zhen) Electronics Limited	Shenzhen	Guangdong	Contract manufacturer	19
Shenzhen MED-Link Electronics Tech Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	18
Sanbor Medical Xiamen, Inc.	Xiamen	Fujian	Contract manufacturer	16
ATL Technology DG,Ltd.	Dongguan	Guangdong	Contract manufacturer	14
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Guangzhou Huada Biotechnology Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	9

Showing 12 of 65. All 65 manufacturers in China registered for Electrosurgical, Cutting & Coagulation & Accessories

Record

Regulatory record for Radio Frequency System
Listed by	Shenzhenshi Sincoheren S&T Development Co., Ltd., China
FDA product code	GEI
Device type	Electrosurgical, Cutting & Coagulation & Accessories
Device class	Class 2
Regulation	21 CFR 878.4400
510(k)	K231749
Record published	2023-11-17

Specifications

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

Catalogue Numbers

Catalogue numbers for Radio Frequency System
Catalogue number	Size	Status
RF-301		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Surgical Direct	Surgical Direct, Inc.	5,729
Speedlock	National Advanced Endoscopy Devices, Inc.	5,212
Stingray Surgical Products	Stingray Surgical Products L.L.C.	4,647
Kirwan	Kirwan Surgical Products, LLC.	1,901
Millennium	Avalign Technologies, Inc.	1,779
DANmed	Dannoritzer Medizintechnik GmbH & Co. KG	1,590
Elmed	Elmed, Inc.	1,519
Symmetry Olsen	Aspen Surgical Products, Inc.	1,219
Guenter Bissinger Medizintechnik GmbH	Günter Bissinger Medizintechnik GmbH	1,117
Ambler Surgical	Ambler Surgical, LLC	756
V. Mueller	Steris Corporation	661
Aesculap	Aesculap AG	544

Showing 12 of 2,922. All products under Electrosurgical, Cutting & Coagulation & Accessories

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231749	2023-10-19

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.