Powered Laser Surgical Instrument
Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC…
Fiber Probe for Magnetic Resonance Imaging, core 272µm, clad 300µm, fiber OD 420µm, transparent Nylon Jacket, freestanding SMA 905, black protection cap, extension sleeve silver, black PVC protection tube OD 1,5mm over 3m+/-0,1m on the proximal side, fiber stop green 235mm +/-1mm from distal end, distal flat tip, cleaved, NA 0.22, length 10m +/-0,05m, sterile EO, disposable, double packed
92manufacturers in China registered for this device type
38catalogue numbers in this listing
1510(k) clearance
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 | Oberon Gmbh Fiber Technologies, Germany |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K140470 |
| Record published | 2024-06-11 |
| Record revised | 2023-06-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Laser Surgery Fiber – DiLA’S® Hemorrhoid Probe | In distribution | |
| Fiber Optic for PLA Long yellow | In distribution | |
| Laser Surgery Fiber 600µm | In distribution | |
| Fiber Optic for PLA Long blue | In distribution | |
| Dental Surgery Fiber 320µm | In distribution | |
| General Surgery Fiber 400um | In distribution | |
| Fiber Optic for PLA Short green | In distribution | |
| Laser Surgery Fiber – DiLA’S® Laser Thyroid Probe | In distribution | |
| Laser Surgery Fiber 600µm | In distribution | |
| Fiber Optic for MRI yellow | In distribution | |
| Fiber Optic for PLA Long green | In distribution | |
| Laser Surgery Fiber – DiLA’S® Fistula Probe | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 400µm Vein | In distribution | |
| Laser Surgery Fiber – DiLA’S® Laser PLDD Probe | In distribution | |
| Corona 360 Radial Fiber 600µm | In distribution | |
| Fiber Optic for PLA Long red | In distribution | |
| Laser Surgery Fiber 600µm | In distribution | |
| Fiber Optic for MRI blue | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 400µm | In distribution | |
| Corona 360 Fiber 600µm | In distribution | |
| Fiber Optic for MRI green | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 600µm | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 600µm Stopper | In distribution | |
| Laser Surgery Fiber – Chirurgie Bare Fiber 320µm | In distribution | |
| Laser Surgery Fiber 600µm | In distribution | |
| Fiber Optic for PLA Short yellow | In distribution | |
| Radial Emission Fiber 400µm | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 600µm Vein | In distribution | |
| Fiber Optic for MRI red | In distribution | |
| Laser Surgery Fiber – DiLA’S® Radial Venous Probe | In distribution | |
| Laser Surgery Fiber – DiLA’S® Slenderflex Venous Probe | In distribution | |
| Laser Surgery Fiber 272µm | In distribution | |
| Laser Surgery Fiber – Dental Bare Fiber 200µm | In distribution | |
| Fiber Optic for PLA Short blue | In distribution | |
| Laser Surgery Fiber – Dental Bare Fiber 320µm | In distribution | |
| Fiber Optic for PLA Short red | In distribution | |
| Laser Surgery Fiber 600µm 2.6m | In distribution | |
| Laser Surgery Fiber – Radial Emission Fiber 400µm Stopper | 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 |
|---|---|
| K140470 | 2014-10-15 |
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.