FiberTech®
27 catalogue numbers from FT IR400/440PI-3/SM-F 500211L, listed by Leoni Fiber Optics, Inc., United States, under Powered Laser Surgical Instrument. 92 manufacturers in China are registered for 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 | Leoni Fiber Optics, Inc., United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| 510(k) | K050738 |
| Record published | 2016-09-29 |
| Record revised | 2023-06-02 (version 6) |
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 |
| Packaging | Pack of 2, pack of 5, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FT IR400/440PI-3/SM-F 500211L | In distribution | |
| FT IR200/240ST-3/SL-F 1500K3L | In distribution | |
| FT IR600/720HCN-3/SL-SF-1750 003711C | In distribution | |
| FT IR550/605ST-3/SL-F 1500K3L | In distribution | |
| FT IR400T-3/SGFM-F 000031L | In distribution | |
| FT IR600/720HCN-3/SL-SF-2050 L12011F | In distribution | |
| FT IR400/420HCT-3/SL-F 130011L | In distribution | |
| FT IR210/220A-2.5/SM-EC23 000311L | In distribution | |
| FT IR600/720HCN-3/SL-SF-2050 L12011F | In distribution | |
| FT IR200/220PI-2.5/SMI-EC23 5K0CK1F | In distribution | |
| FT IR600T-3/SGFM-F 000021L | In distribution | |
| FT IR210/220A-2.5/SM-ES23 000311L | In distribution | |
| FT IR200/240ST-3/SL-F 120011L | In distribution | |
| FT IR365/400ST-3/SL-F 1500K3L | In distribution | |
| FT IR600/720HCN-3/SF-2050 003001C | In distribution | |
| FT IR210/220A-2.5/SM-EC25 000311L | In distribution | |
| FT IR600/720HCN-3/SL-SF-2000 012011L | In distribution | |
| FT IR400/440PI-3/SM-F 500211L | In distribution | |
| FT IR273/300ST-3/SL-F 120011L | In distribution | |
| FT UV100/240AN-2.5/SM-EC23 300311L | In distribution | |
| FT IR365/400ST-3/SL-F 120011L | In distribution | |
| FT IR550/605ST-3/SL-F 120011L | In distribution | |
| FT IR210/220A-2.5/SM-ES25 000311L | In distribution | |
| FT IR600/660HCT-3/SL-F 130011L | In distribution | |
| FT IR600/720HCN-3/SL-SF-2050 0S2011F | In distribution | |
| FT IR200/220PI-2.5/SMI-ES23 5K0CK1F | In distribution | |
| FT IR272/300ST-3/SL-F 1500K3L | 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 |
|---|---|
| K201171 | 2021-04-02 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Leoni Fiber Optics, Inc. | 510(k) number | 2018-10-17 | Class II | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartsco | 2020-04-10 |
| Leoni Fiber Optics, Inc. | 510(k) number | 2018-10-17 | Class II | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartsco | 2020-04-10 |
| Leoni Fiber Optics, Inc. | 510(k) number | 2018-10-17 | Class II | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartsco | 2020-04-10 |
| Leoni Fiber Optics, Inc. | 510(k) number | 2018-10-17 | Class II | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartsco | 2020-04-10 |
| Leoni Fiber Optics, Inc. | 510(k) number | 2018-10-17 | Class II | Packaging | A percentage of the products shipped in Smartscope single-box packaging may exhibit a broken package seal, thus having compromised sterility. There have been two reports of compromised sterility; however, all products packaged in Smartsco | 2020-04-10 |
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.