Flexiva Pulse ID
Flexiva Pulse and Flexiva Pulse TracTip laser fibers are high power single-use fiber
92manufacturers in China registered for this device type
5catalogue numbers in this listing
11510(k) clearances naming this product code
23recalls on this 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 | Boston Scientific Corporation, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2021-05-01 |
| Record revised | 2025-09-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 5 |
| Sizes | Length 2.6 to 3 m |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M006L8406940 | Length 2.6 m | In distribution |
| M006L8406930 | Length 2.6 m | In distribution |
| M006L8406960 | Length 3.0 m | In distribution |
| M006L8406920 | Length 2.6 m | In distribution |
| M006L8406910 | Length 3.0 m | 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 |
|---|---|
| K260100 | 2026-05-18 |
| K252529 | 2025-10-30 |
| K251759 | 2025-07-09 |
| K210925 | 2021-04-28 |
| K140503 | 2014-04-15 |
| K110685 | 2011-03-29 |
| K110686 | 2011-03-28 |
| K100078 | 2010-02-12 |
| K093691 | 2009-12-11 |
| K082928 | 2008-10-16 |
| K933715 | 1993-11-22 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Boston Scientific Corporation | UDI-DI | 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 112 units |
| Boston Scientific Corporation | UDI-DI | 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 205 units |
| Boston Scientific Corporation | UDI-DI | 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 231 units |
| Boston Scientific Corporation | UDI-DI | 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 280 units |
Recalls
18 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 3 are recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 66 units | |
| 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 339 units | |
| 2023-05-25 | Class II | Nonconforming Material/Component | Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which | 1245 units | |
| 2022-05-31 | Class III | Software Manufacturing/Software Deployment | Several complaints were received for the affected lot; users received a “Fiber type does not match card type” error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and fiber card. This may resul | 57 | |
| 2020-03-30 | Class II | Use error | To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints. | 146,633 | 2023-04-05 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 18 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 3 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 3 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 27 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 8 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 1 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 6 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 2 (OUS) | 2023-05-10 |
| 2019-04-08 | Class II | Component design/selection | Certain Auriga consoles may exhibit faster than normal power degradation due to a potential issue in the mechanical cooling system that could lead to a low power error (1301) being displayed on the screen. The console is designed to stop em | 1 (OUS) | 2023-05-10 |
| 2017-09-22 | Class II | Process design | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. | 9 | 2018-08-14 |
| 2017-09-22 | Class II | Process design | Certain Auriga consoles have incorrectly assembled trigger wire components. The trigger wire functions in the start-up of the console. An incorrectly assembled trigger wire may result in error codes or failure to start the console. | 2 | 2018-08-14 |
| 2014-09-30 | Class II | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system | 33 units | 2014-11-26 |
| 2014-09-30 | Class II | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system | 5 units | 2014-11-26 |
| 2014-09-30 | Class II | No Marketing Application | Product is not cleared for use with lasers other than the Auriga XL system | 7 units | 2014-11-26 |
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.