Laser Surgery Fibers and Probes
A.R.C. Laser Surgery Fibers and Probes transmit energy from a compatible surgical laser to soft tissue. Their quartz-core fibres connect proximally through an SMA 905 connector, while the…
A.R.C. Laser Surgery Fibers and Probes transmit energy from a compatible surgical laser to soft tissue. Their quartz-core fibres connect proximally through an SMA 905 connector, while the distal end delivers the laser output to the target.
Bare distal tips may be flat or spherical and can be used with suitable sterile handpieces. The fibres support contact or noncontact delivery, including use through endoscopes.
Listed Item
Bare fiber 400 micrometer universal centering 1470 nm
Fibre Configurations
The family includes approximately 2 to 3 metre fibres and wavelength configurations spanning 450 to 2,100 nm. Pulsed or continuous-wave operation depends on the compatible laser setup. The delivery devices are supplied ethylene-oxide-sterilized for single use.
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 | A.R.C. Laser Gmbh, Germany |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K161403 |
| Record published | 2016-10-28 |
| Record revised | 2023-06-02 (version 8) |
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, serial number |
| Packaging | Pack of 5, pack of 30, pack of 15 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LL13025s | In distribution | |
| LL28059s | In distribution | |
| LL13008s | In distribution | |
| LL13011s | In distribution | |
| LL13066s | In distribution | |
| LL13015s | In distribution | |
| LL11058s | In distribution | |
| LL28068s | In distribution | |
| LL11059s | In distribution | |
| LL13062s | In distribution | |
| LL13001s | In distribution | |
| LL13003s | In distribution | |
| LL13006s | In distribution | |
| LL13034s | In distribution | |
| LL28006s | In distribution | |
| LL13014s | In distribution | |
| LL28066s | In distribution | |
| LL11057s | In distribution | |
| LL13010s | In distribution | |
| LL28008s | In distribution | |
| LL28058s | In distribution | |
| LL13017s | In distribution | |
| LL11053s | In distribution | |
| LL28001s | In distribution | |
| LL13009s | In distribution | |
| LL28062s | 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 |
|---|---|
| K220531 | 2022-09-01 |
| K192272 | 2020-03-17 |
| K161403 | 2016-08-16 |
| K091059 | 2009-08-13 |
| K073322 | 2008-02-22 |
| K001511 | 2000-07-19 |
| K993154 | 2000-06-29 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2003-06-06 | Not classified | Other | Product may not have been properly sterilized. | 370 units | 2003-07-23 |
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.