Neogen
The NeoGen PSR System is an electrosurgical system intended for treatment of listed skin conditions. The FDA filing names the NeoGen PSR System and describes controlled heating of the…
The NeoGen PSR System is an electrosurgical system intended for treatment of listed skin conditions. The FDA filing names the NeoGen PSR System and describes controlled heating of the skin’s outer layers with thermal modification to the dermis.
The listed conditions include wrinkles and rhytides, superficial skin lesions, actinic keratosis, viral papillomata, seborrheic keratosis and acne scars. The filing describes a generator, handpiece and nozzle assembly using nitrogen gas to produce plasma pulses.
Listed Item
A mobile assembly of devices intended to treat a variety of skin conditions (e.g., acne scars, actinic keratosis, wrinkles, superficial skin lesions, warts) through controlled heating of the skin surface via application of nitrogen plasma. It consists of a mains electricity (AC-powered) generator/control unit and a hand-held applicator; it may include a N2 cylinder(s) and additional hardware (e.g., foot-switch). Typically radio-frequency energy is used to convert N2 into N2 plasma which exits the handpiece as a pulsed beam. This device is intended to be used by a professional in a clinical setting.
System Operation
The filing says generator energy converts nitrogen gas into plasma in the handpiece, and the plasma exits through a nozzle toward the skin. Energy per pulse is user-adjustable from 1 to 4 joules for a standard nozzle.
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.
| 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
| Listed by | Energist Limited, United Kingdom |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K132754 |
| Record published | 2021-05-13 |
| Record revised | 2026-04-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal |
| Packaging | Carton of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Handpiece Blk | In distribution | |
| NeoGen 5mm 1x Nozzle (Black) | In distribution | |
| Handpiece Gry | In distribution | |
| NeoGen 25mm 1x Nozzle (Black) | In distribution | |
| NeoGen 5mm 3x Nozzle (Grey) | In distribution | |
| NeoGen 25mm 1x Nozzle (Grey) | In distribution | |
| SPA Grey Trolley | In distribution | |
| NeoGen 5mm 1x Nozzle (Grey) | In distribution | |
| NeoGen 25mm 3x Nozzle (Black) | In distribution | |
| Trolley Gry | In distribution | |
| PSR | In distribution | |
| NeoGen 5mm 3x Nozzle (Black) | In distribution | |
| Trolley Blk | In distribution | |
| NeoGen 25mm 3x Nozzle (Grey) | In distribution |
Same 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
| Clearance | Decision date |
|---|---|
| K221873 | 2023-01-12 |
| K132754 | 2013-12-12 |
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.