Edge Handpiece
Edge Surgical Handpiece F100
12manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (7), Jiangsu (2), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Beijing Beautemax Technology Limited | Beijing | Beijing | Contract manufacturer | 13 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Beijing Perfectlaser Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 12 |
| Sanhe Jumei Technology Co., Ltd. | Sanhe | Hebei | Manufacturer | 12 |
| Beijing SEA Heart International Science AND Technology Co., Ltd. | Beijing | Beijing | Exporter | 7 |
| Shanghai Apolo Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Beijing Sincoheren Science & Technology Development Co., Ltd. | Bejing | Beijing | Repacker / relabeller | 5 |
| Weifang Mingliang Electronics Co., Ltd. | Weifang | Shandong | Manufacturer | 2 |
| Wingderm Electro-Optics Ltd. | Beijing | Beijing | Manufacturer | 2 |
| Olemy Laser Technology Ltd | Wuxi | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Jeisys Medical Inc., South Korea |
|---|---|
| FDA product code | ONG |
| Device type | Powered Laser Surgical Instrument With MicrobeamFractional Output |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K162169 |
| Record published | 2026-07-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Edge Fractional Handpiece | In distribution | |
| Edge Surgical Handpiece F100 | In distribution | |
| Edge Surgical Handpiece F50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| eCO2 3D | Cynosure Lutronic Technology Corporation | 18 |
| Clear & Brilliant | Solta Medical, Inc. | 8 |
| Clear+brilliant Touch | Solta Medical, Inc. | 7 |
| Edge Guide Tip | Jeisys Medical Inc. | 5 |
| Apolomed | Shanghai Apolo Medical Technology Co., Ltd. | 3 |
| Emerge | Cynosure, LLC | 2 |
| Miria | Avava, Inc. | 2 |
| Max R Handpiece | Cynosure, LLC | 2 |
| Smooth Beauty Laser | Tria Laser Inc | 2 |
| 1064+ Handpiece | Cynosure, LLC | 2 |
| Stellar™ M22 | Lumenis, Ltd. | 2 |
| Emerge Handpiece | Cynosure, LLC | 2 |
Showing 12 of 59. All products under Powered Laser Surgical Instrument With MicrobeamFractional Output
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.