ScopeSafe™Laser Fiber
272 micrometer ScopeSafe laser Fiber With SMA 905 Connector and Resistive Interlocking Sleeve
92manufacturers in China registered for this device type
39catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Optical Integrity, 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, Manufacturer |
| 510(k) | K022338 |
| Record published | 2016-07-28 |
| Record revised | 2023-06-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 10 to 37 °C; Special storage condition: store at room temperature |
| Packaging | Box of 3 |
| Sizes | Outer diameter 200 to 1000 µm |
| Distribution end date | 2017-03-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10645 | Outer Diameter 200 µm | In distribution |
| 10369 | fiber core diameter | In distribution |
| 10849 | Outer Diameter 550 µm | In distribution |
| 10591 | Outer Diameter 300 µm | In distribution |
| 10846 | fiber core diameter | In distribution |
| 10966 | Outer Diameter 272 µm | In distribution |
| 10625 | Outer Diameter 272 µm | In distribution |
| 10560 | Outer Diameter 272 µm | In distribution |
| 10728 | Outer Diameter 272 µm | In distribution |
| 10683 | Outer Diameter 272 µm | In distribution |
| 10236 | fiber core diameter | In distribution |
| 10212 | Outer Diameter 300 µm | In distribution |
| 10388 | fiber core diameter | In distribution |
| 10719 | Outer Diameter 300 µm | In distribution |
| 10368 | Outer Diameter 365 µm | In distribution |
| 10626 | fiber core diameter | In distribution |
| 11211 | fiber core diameter | In distribution |
| 10842 | Outer Diameter 300 µm | In distribution |
| 10840 | fiber core diameter | In distribution |
| 10902 | Outer Diameter 300 µm | In distribution |
| 10366 | fiber core diameter | In distribution |
| 10367 | fiber core diameter | In distribution |
| 10847 | fiber core diameter | In distribution |
| 10370 | Outer Diameter 940 µm | In distribution |
| 10681 | Outer Diameter 200 µm | In distribution |
| 10848 | fiber core diameter | In distribution |
| 10211 | fiber core diameter | In distribution |
| 10841 | Outer Diameter 272 µm | In distribution |
| 10850 | fiber core diameter | In distribution |
| 27750200U1 | fiber core diameter | Withdrawn |
| P00120300SS | Outer Diameter 300 µm | Withdrawn |
| P00120272SS | fiber core diameter | Withdrawn |
| P00120200SS | Outer Diameter 200 µm | Withdrawn |
| 27750940U1 | fiber core diameter | Withdrawn |
| P00120300SSR | fiber core diameter | Withdrawn |
| 27750300U1 | Outer Diameter 300 µm | Withdrawn |
| 27750365U1 | Outer Diameter 365 µm | Withdrawn |
| 27750272U1 | fiber core diameter | Withdrawn |
| 27750550U1 | fiber core diameter | Withdrawn |
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 |
|---|---|
| K100194 | 2010-05-20 |
| K022338 | 2002-10-16 |
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.