ProFlex™
Maximum Power (J x PPS): 120W. Compatible with Trimedyne Omnipulse Lasers: Not a Trimedyne Product.
92manufacturers in China registered for this device type
109catalogue numbers in this listing
6510(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 | Innovaquartz LLC, United States |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K142638 |
| Record published | 2016-09-17 |
| Record revised | 2023-06-02 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2016-09-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Single Use 273 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| 273 Reusable Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| 550 Reusable Laser Lithotripsy Fiber | In distribution | |
| Reusable 200 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| 273 Single-Use Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 365 Laser Lithotripsy Fiber | In distribution | |
| SU1000PF | In distribution | |
| TSU365PF | In distribution | |
| Single Use 550 Laser Lithotripsy Fiber | In distribution | |
| 273 Single-Use Laser Lithotripsy Fiber | In distribution | |
| LSU200PT | In distribution | |
| DRU200PF | In distribution | |
| 273 Reusable Laser Lithotripsy Fiber | In distribution | |
| Reusable 365 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Reusable 200 Laser Lithotripsy Fiber | In distribution | |
| TRU200PF | In distribution | |
| Single Use 150 Laser Lithotripsy Fiber | In distribution | |
| Single Use 273 Laser Lithotripsy Fiber var. ProTrac | In distribution | |
| 365 Single-Use Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 200 Laser Lithotripsy Fiber var. SPY | In distribution | |
| 200 Single-Use Laser Lithotripsy Fiber | In distribution | |
| 910 Reusable Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Reusable 910 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| TRU273PF | In distribution | |
| 550 Reusable Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 150 Laser Lithotripsy Fiber var. SPY | In distribution | |
| Single Use 273 Laser Lithotripsy Fiber | In distribution | |
| Reusable 365 Laser Lithotripsy Fiber | In distribution | |
| Single Use 365 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 910 Laser Lithotripsy Fiber | In distribution | |
| 273 Single-Use Laser Lithotripsy Fiber | In distribution | |
| LSU200PF | In distribution | |
| DSU200PT | In distribution | |
| Single Use 273 Laser Lithotripsy Fiber var. SPY Trimedyne | In distribution | |
| TSU200PF | In distribution | |
| 200 Reusable Laser Lithotripsy Fiber | In distribution | |
| Reusable 150 Laser Lithotripsy Fiber | In distribution | |
| DSU273PF | In distribution | |
| 365 Reusable Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| SU365PF | In distribution | |
| LSU273PF | In distribution | |
| DRU273PF | In distribution | |
| Single Use 365 Laser Fiber var. Aurora™ | In distribution | |
| Single Use 910 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 200 Laser Lithotripsy Fiber | In distribution | |
| 200 Reusable Laser Lithotripsy Fiber | In distribution | |
| 910 Single-Use Laser Lithotripsy Fiber | In distribution | |
| 365 Single-Use Laser Lithotripsy Fiber | In distribution | |
| Reusable 365 Laser Fiber var. Aurora™ | In distribution | |
| LSU273PT | In distribution | |
| 910 Reusable Laser Lithotripsy Fiber | In distribution | |
| Reusable 273 Laser Lithotripsy Fiber | In distribution | |
| TSU273PF | In distribution | |
| Reusable 910 Laser Lithotripsy Fiber | In distribution | |
| RU550PF | In distribution | |
| 365 Reusable Laser Lithotripsy Fiber | In distribution | |
| Single Use 273 Laser Lithotripsy Fiber var. SPY | In distribution | |
| Reusable 550 Laser Fiber var. Aurora™ | In distribution | |
| TSU1000PF | In distribution | |
| Single Use 200 Laser Lithotripsy Fiber var. ProTrac | In distribution | |
| TSU550PF | In distribution | |
| 910 Single-Use Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| 550 Single-Use Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| SU550PF | In distribution | |
| 200 Reusable Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Reusable 273 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| RU1000PF | In distribution | |
| TRU365PF | In distribution | |
| Single Use 200 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Reusable 550 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 365 Laser Lithotripsy Fiber var. SPY | In distribution | |
| 273 Reusable Laser Lithotripsy Fiber | In distribution | |
| DSU273PT | In distribution | |
| RU365PF | In distribution | |
| 200 Single-Use Laser Lithotripsy Fiber | In distribution | |
| TRU1000PF | In distribution | |
| 550 Single-Use Laser Lithotripsy Fiber | In distribution | |
| TRU550PF | In distribution | |
| Single Use 365 Laser Lithotripsy Fiber var. SPY Trimedyne | In distribution | |
| Single Use 550 Laser Lithotripsy Fiber var. Trimedyne | In distribution | |
| Single Use 550 Laser Lithotripsy Fiber var. AU | In distribution | |
| Reusable 550 Laser Lithotripsy Fiber | In distribution | |
| LRU200PF | In distribution | |
| 200 Single-Use Laser Lithotripsy Fiber | In distribution | |
| DSU200PF | In distribution | |
| LRU273PF | In distribution | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | Withdrawn | |
| Laser Lithotripsy Fiber | 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 |
| 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 |
| LightScalpel | Lightscalpel Inc | 47 |
Showing 12 of 2,654. All products under Powered Laser Surgical Instrument
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233157 | 2024-05-03 |
| K203799 | 2021-09-20 |
| K180140 | 2018-04-20 |
| K142638 | 2014-12-19 |
| K050108 | 2005-03-14 |
| K994010 | 1999-12-17 |
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.