Dornier MedTech
10 Units of 600 Micron Disposable ND YAG Laser Lightguide with Rinsing Tube, 3.5 meter length, 1.8 mm outer diameter
92manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | Dornier Medtech Gmbh, Germany |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070536 |
| Record published | 2018-09-11 |
| Record revised | 2024-02-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 400 Micron Disposable NA 0.22 | In distribution | |
| Medilas D MultiBeam (D-Plug) | In distribution | |
| 600 Micron Disposable | In distribution | |
| Medilas D LiteBeam+ (D-Plug) | In distribution | |
| 600 Micron D Luer/SMA Calibration | In distribution | |
| Medilas D LiteBeam+ (1470 SMA) | In distribution | |
| Medilas HRM Laser | In distribution | |
| 600 Micron Disposable | In distribution | |
| 400 Micron Disposable NA 0.37 | In distribution | |
| Medilas HRM Laser | In distribution | |
| 600 Micron Disposable Nozzle Tip | In distribution | |
| Medilas D MultiBeam (D-Plug) | In distribution | |
| Medilas H30 Laser | In distribution | |
| Medilas D30 1064 (SMA) | In distribution | |
| 600 Micron Disposable Barefiber | In distribution | |
| 400 Micron Disposable NA 0.37 | In distribution | |
| 600 Micron Disposable Nozzle Tip | In distribution | |
| 550 Micron 5X Reusable | In distribution | |
| 600 Micron Disposable Rinsing Tube | In distribution | |
| Medilas H30 Laser | In distribution | |
| Medilas H35 Laser | In distribution | |
| 600 Micron Disposable Nozzle Tip | In distribution | |
| Medilas Fibertome 8100 | In distribution | |
| Medilas D LiteBeam+ (1470 D-Plug) | In distribution | |
| Medilas D FlexiPulse (D-Plug) | In distribution | |
| 600 Micron Disposable | In distribution | |
| Medilas H35 Laser | In distribution | |
| 600 Micron ND Calibration | In distribution | |
| Medilas H30 Laser | 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
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.