MultiPulse TM+1470
The MultiPulse Tm+1470 is a surgical laser system for soft-tissue procedures performed through open, laparoscopic or endoscopic approaches. Its uses include incision, excision, resection,…
The MultiPulse Tm+1470 is a surgical laser system for soft-tissue procedures performed through open, laparoscopic or endoscopic approaches. Its uses include incision, excision, resection, ablation, vaporisation, coagulation and haemostasis across the stated surgical specialties.
The system combines a 1940 nm thulium:YAG source with a 1470 nm near-infrared diode laser module. Optical fibers transmit the output to the treatment site, with continuous-wave or pulsed operation selected through the touchscreen and footswitch.
Listed Item
Surgical laser with 2 laser modules of 1940 nm and 1470 nm (both near infrared). Intended for surgical procedures using open, laparoscopic and endoscopic procedures of soft tissue in many medical specialties.
System Components
A power supply, water-cooling unit and control electronics support the laser sources. The paired wavelengths and compatible optical fibers provide the system’s surgical energy delivery configuration.
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 | Asclepion Laser Technologies GmbH, Germany |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K133891 |
| Record published | 2016-09-29 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1901 | 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 |
|---|---|
| K261094 | 2026-04-29 |
| K253100 | 2025-10-23 |
| K241600 | 2024-07-03 |
| K240816 | 2024-04-23 |
| K231876 | 2024-02-22 |
| K213889 | 2022-04-22 |
| K210634 | 2022-04-13 |
| K192483 | 2020-03-13 |
| K161257 | 2017-03-31 |
| K152153 | 2015-12-11 |
| K150140 | 2015-06-05 |
| K143519 | 2015-03-10 |
| K133891 | 2015-01-30 |
| K131987 | 2014-10-15 |
| K131757 | 2014-07-17 |
| K133297 | 2014-06-10 |
| K113489 | 2012-07-27 |
| K112669 | 2012-05-11 |
| K111851 | 2011-07-08 |
| K081541 | 2009-02-23 |
| K071451 | 2007-08-01 |
| K060787 | 2006-09-27 |
| K060457 | 2006-03-20 |
| K060455 | 2006-03-20 |
| K060459 | 2006-03-20 |
| K050900 | 2005-05-16 |
| K042968 | 2004-11-24 |
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.