Boston Aesthetics
17 catalogue numbers from Unicorn+ I, listed by Shenzhen Peninsula Medical Group, China, under Electrosurgical, Cutting & Coagulation & Accessories. 65 manufacturers in China are registered for this product code.
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 | Shenzhen Peninsula Medical Group, China |
|---|---|
| FDA product code | GEI |
| Device type | Electrosurgical, Cutting & Coagulation & Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K254290 |
| Record published | 2025-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Unicorn+ I | In distribution | |
| MicroRF 25N | In distribution | |
| Artist D4.5 | In distribution | |
| Unicorn+ III | In distribution | |
| MicroRF 25 | In distribution | |
| Unicorn+ II | In distribution | |
| Pure+ B1 | In distribution | |
| Artist D2.0 | In distribution | |
| Unicorn+ | In distribution | |
| Unicorn+ I | In distribution | |
| MicroRF 49 | In distribution | |
| Unicorn+ III | In distribution | |
| Artist D6.0 | In distribution | |
| MicroRF 9N | In distribution | |
| Unicorn+ | In distribution | |
| Artist D3.5 | In distribution | |
| Unicorn+ II | 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 |
|---|---|
| K254290 | 2026-01-30 |
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.