Dornier MedTech
Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 2.1mm Nozzle 3.5m
92manufacturers in China registered for this device type
91catalogue numbers in this listing
25510(k) clearances naming this product code
1recall
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 America, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K121938 |
| Record published | 2018-04-10 |
| Record revised | 2023-12-04 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 3, pack of 3, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000 Micron Single Use | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Reusable, RFID (slim) | In distribution | |
| 1000 Micron SU Thulio Performance 3m Fiber | In distribution | |
| 270 Micron SU Thulio Performance Ball-Tip 3m Fiber | In distribution | |
| Slim 270 Micron Ball Tip Single Use | In distribution | |
| Dornier SingleFlex 200 High Energy Ball Tip Laser Fiber | In distribution | |
| 1000 micron Holmium Laser Fiber Cable, Reusable, French Cycle, RFID | In distribution | |
| Dornier 600 µm Single-Use SMA Diode Laser Fiber 2.5m | In distribution | |
| Dornier 600 µm Single-Use SMA Diode Laser Fiber with Adjustable Rinsing Tube 3.5 | In distribution | |
| DMTL SmartFlex 270 High Energy Reusable (5X) | In distribution | |
| 600 micron single use luer lock | In distribution | |
| 270 Micron SU Thulio Slim Performance 3m Fiber | In distribution | |
| 200 Micron SU Thulio High Performance 3m Fiber | In distribution | |
| THULIO LL-R TM 200µM 3M PERF. FIBER 3ST 10X USE | In distribution | |
| 270 Micron Single Use | In distribution | |
| 200 Series Flex Single Use | In distribution | |
| 365 micron single use luer lock | In distribution | |
| 600 Micron Single Use | In distribution | |
| 200 Micron Ball Tip Single Use HE | In distribution | |
| 200 Series Reusable | In distribution | |
| Slim 270 Micron Single Use | In distribution | |
| 200 Series Single Use | In distribution | |
| 400 micron Holmium Laser Fiber Cable, Reusable, French Cycle, RFID | In distribution | |
| Dornier 400 µm Single-Use SMA Diode Laser Fiber 2.5m | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Single Use, RFID | In distribution | |
| 400 micron Holmium Laser Fiber Cable, Single Use, RFID (4.5 meter) | In distribution | |
| 400 Micron Single Use | In distribution | |
| 600 micron Holmium Laser Fiber Cable, Single Use, RFID | In distribution | |
| Dornier Medilas H 270 Micron Single Use Ball Tip Laser Fiber – LATAM | In distribution | |
| 400 Micron SU Thulio Performance 3m Fiber | In distribution | |
| 1000 Micron Reusable | In distribution | |
| 400 micron Holmium Laser Fiber Cable, Single Use, RFID | In distribution | |
| 400 Micron Reusable HE | In distribution | |
| 400 Micron Reusable | In distribution | |
| 1000 Micron Reusable | In distribution | |
| Dornier 550 µm Single-Use SMA UroBeam Diode Laser Fiber 3.5m | In distribution | |
| 1000 Micron Reusable HE | In distribution | |
| 1000 micron Holmium Laser Fiber Cable, Reusable, RFID | In distribution | |
| 600 micron Holmium Laser Fiber Cable, Reusable, RFID | In distribution | |
| Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 2.1mm No | In distribution | |
| 200 Micron SU Thulio Performance Ball-Tip 3m Fiber | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Reusable, RFID | In distribution | |
| 600 micron slim single use luer lock | In distribution | |
| Dornier 600 µm Single-Use SMA Diode Laser Fiber with Fixed Rinsing Tube 1.8mm No | In distribution | |
| Dornier 400 µm Single-Use ND YAG Laser Fiber 3.5m | In distribution | |
| 400 micron single use SMA | In distribution | |
| DMTL SmartFlex 400 High Energy Reusable (5X) | In distribution | |
| 600 Micron SU Thulio Performance 3m Fiber | In distribution | |
| 600 micron single use SMA | In distribution | |
| 1000 Micron Single Use HE | In distribution | |
| 600 Micron Single Use | In distribution | |
| Slim 270 Micron Reusable | In distribution | |
| 400 Micron Reusable | In distribution | |
| 400 micron Holmium Laser Fiber Cable, Reusable, RFID | In distribution | |
| 1000 Micron Single Use | In distribution | |
| 400 Micron Single Use HE | In distribution | |
| Dornier Medilas H 400 Micron Single Use Laser Fiber – LATAM | In distribution | |
| 600 micron single use luer lock | In distribution | |
| DMTL SmartFlex 200 High Energy Reusable (5X) | In distribution | |
| 400 Micron Single Use | In distribution | |
| 400 micron single use luer lock | In distribution | |
| 270 Micron Single Use | In distribution | |
| 400 micron single use luer lock | In distribution | |
| 270 Micron Reusable HE | In distribution | |
| 270 Micron Reusable | In distribution | |
| Holmium 400um 3M Fiber 3ST 10X Use – LATAM Non-RFID Reusable | In distribution | |
| Dornier Medilas H 270 Micron Single Use Laser Fiber – LATAM | In distribution | |
| Dornier 600 µm Single-Use ND YAG Laser Fiber 3.5m | In distribution | |
| Holmium 270um 3M Fiber 3ST 10X Use- LATAM Non-RFID Reusable | In distribution | |
| 600 Micron Reusable | In distribution | |
| 270 Micron Single Use HE | In distribution | |
| 1000 micron Holmium Laser Fiber Cable, Single Use, RFID | In distribution | |
| THULIO LL-R TM 400µM 3M PERF. FIBER 3ST 10X USE | In distribution | |
| 200 Micron Reusable HE | In distribution | |
| DMTL SmartFlex 600 High Energy Reusable (5X) | In distribution | |
| 400 Micron SU Thulio Performance 4.5m Fiber | In distribution | |
| 600 Micron Single Use HE | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Single Use, RFID (slim) | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Reusable, French Cycle, RFID | In distribution | |
| 270 Micron SU Thulio Performance 3m Fiber | In distribution | |
| 270 Micron Reusable | In distribution | |
| 600 Micron Reusable | In distribution | |
| DMTL SmartFlex 1000 High Energy Reusable (5X) | In distribution | |
| THULIO LL-R TM 600µM 3M PERF. FIBER 3ST 10X USE | In distribution | |
| THULIO LL-R TM 1000µM 3M PERF. FIBER 3ST 10X USE | In distribution | |
| 270 micron Holmium Laser Fiber Cable, Single Use, RFID (slim, ball tip) | In distribution | |
| 600 micron Holmium Laser Fiber Cable, Reusable, French Cycle, RFID | In distribution | |
| 600 Micron Reusable HE | In distribution | |
| THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USE | In distribution | |
| 200 Micron Single Use HE | In distribution | |
| Dornier 600 µm Single-Use SMA UroBeam Diode Laser Fiber 3.5m | 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 |
| 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 |
| LightScalpel | Lightscalpel Inc | 47 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213252 | 2022-07-27 |
| K180350 | 2018-03-07 |
| K161771 | 2016-07-28 |
| K152591 | 2015-10-08 |
| K130344 | 2013-03-21 |
| K122159 | 2013-02-01 |
| K123385 | 2012-12-14 |
| K121938 | 2012-08-01 |
| K110364 | 2011-12-07 |
| K083500 | 2009-02-12 |
| K083258 | 2009-01-30 |
| K073427 | 2008-08-20 |
| K080959 | 2008-06-27 |
| K070536 | 2007-05-21 |
| K061455 | 2006-08-01 |
| K020339 | 2002-10-25 |
| K022544 | 2002-08-21 |
| K021724 | 2002-08-19 |
| K011322 | 2001-11-19 |
| K983963 | 1998-11-25 |
| K964760 | 1997-02-19 |
| K921549 | 1993-02-18 |
| K913191 | 1991-10-16 |
| K904149 | 1990-12-04 |
| K904155 | 1990-11-21 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-04-01 | Class II | Package design/selection | Pin hole package failures compromising sterility of product | 400 units | 2020-04-20 |
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.