EdgePro
An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a…
An all-tissue dental laser system intended for a variety of oral soft-tissue and hard-tissue procedures. The system includes a top-table laser console with a removable tablet PC as a control panel/user interface, a wireless footswitch and a delivery system comprising of a fiber optic cable, two handpieces and a variety of laser tips. Other system components include protective eyewear, power cords, a tip cleaning kit, tablet protective covers, water reservoir fill kit, etc. The patient-contacting components of the delivery system require sterilization prior to use.
Who Else Makes It
Concentrated in Beijing (28), Guangdong (21), Hebei (13). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Beijing Winkonlaser Technology Limited | Beijing | Beijing | Contract manufacturer | 14 |
| Changsha Gomecy Electronics Co., Ltd. | Changsha | Hunan | Contract manufacturer | 9 |
| Gymmax Technology Shenzhen Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Guangzhou Niansheng Beauty Equipment Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 7 |
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Wuhan Dimed Laser Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| Chengdu Vantron Technology Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 1 |
| Shanghai Shengguang Science & Technology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 1 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
Showing 12 of 92. All 92 manufacturers in China registered for Powered Laser Surgical Instrument
Record
| Listed by | Biolase Technology, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K213428 |
| Record published | 2023-06-19 |
| Record revised | 2026-05-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 45 °C; Storage environment humidity 10 to 90 % RH |
| Packaging | Box of 10, box of 30 |
| Sizes | Length 10 to 25 mm; outer diameter 200 to 500 µm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Tip Assembly – One-21 mm, WL JUNO | Length 21 mm | In distribution |
| Tip Assembly – Two-17mm, WL JUNO | Length 17 mm | In distribution |
| Tip Assembly – One-25 mm, WL JUNO | Length 25 mm | In distribution |
| EdgePro Handpiece | In distribution | |
| Tip Assembly – Two-21mm, WL JUNO | Length 21 mm | In distribution |
| EdgePro Laser System (Juno) | In distribution | |
| Tip Assembly – One-17 mm | Length 17 mm | In distribution |
| Tip Assembly – Three-10mm, WL JUNO | Length 10 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Accu-Beam | Transamerican Technologies International | 181 |
| Powered Laser Surgical Instrument | Weinert Fiber Optics Inc. | 117 |
| Waterlase Laser Tips | Biolase Technology, Inc. | 112 |
| ProFlex™ | Innovaquartz LLC | 109 |
| Dornier MedTech | Dornier Medtech America, Inc. | 91 |
| Powered Laser Surgical Instrument | Ophthalmed LLC | 90 |
| Optilite | Convergent Laser Technologies | 87 |
| Reusable Surgical Optical Fiber | Quanta System Spa | 78 |
| Single use Surgical Optical Fiber | Quanta System Spa | 70 |
| Powered Laser Surgical Instrument | Lutronic Corporation | 57 |
| Waterlase iPlus Dental Laser System | Biolase Technology, Inc. | 53 |
| Leoni™ | Weinert Fiber Optics Inc. | 49 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K210183 | 2022-04-21 |
| K193486 | 2020-03-16 |
| K192430 | 2019-12-04 |
| K190319 | 2019-10-10 |
| K172771 | 2017-11-29 |
| K163128 | 2017-01-11 |
| K161669 | 2016-07-28 |
| K141975 | 2015-03-05 |
| K140120 | 2014-10-10 |
| K122368 | 2013-05-02 |
| K130465 | 2013-04-11 |
| K121327 | 2013-02-01 |
| K121286 | 2012-09-28 |
| K101658 | 2010-08-11 |
| K093852 | 2010-03-12 |
| K091746 | 2009-12-07 |
| K083927 | 2009-10-01 |
| K091922 | 2009-07-14 |
| K090181 | 2009-02-11 |
| K082938 | 2008-12-22 |
| K083069 | 2008-11-13 |
| K081589 | 2008-06-13 |
| K071363 | 2008-02-12 |
| K071734 | 2008-01-25 |
| K061898 | 2007-01-26 |
| K052354 | 2006-07-05 |
| K031140 | 2004-07-07 |
| K030523 | 2004-01-30 |
| K030539 | 2003-10-10 |
| K011041 | 2001-07-03 |
| K003385 | 2001-01-25 |
| K991994 | 1999-09-10 |
| K950248 | 1995-02-24 |
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.