Pallas Arm
The PALLAS Arm is the articulating link that connects the PALLAS laser system’s handpiece to its console. It belongs to the complete system’s optical energy delivery arrangement. The…
The PALLAS Arm is the articulating link that connects the PALLAS laser system’s handpiece to its console. It belongs to the complete system’s optical energy delivery arrangement.
The ultraviolet laser light source is housed in the protective console. The delivery system passes UVB light through the handpiece to the selected skin-treatment site.
Clinical System Context
The complete PALLAS system is intended for UVB phototherapy of psoriasis, vitiligo, atopic dermatitis, and leukoderma. These are treatment indications for the laser system used with the arm.
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 | Laseroptek, South Korea |
|---|---|
| FDA product code | GEX |
| Device type | Powered Laser Surgical Instrument |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Manufacturer |
| 510(k) | K172639 |
| Record published | 2018-01-15 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 0 to 40 °C; Storage environment humidity 20 to 80 % RH; Handling environment temperature 15 to 30 °C; Handling environment humidity 20 to 80 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PALLAS Arm | In distribution | |
| PALLAS Arm | 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 |
|---|---|
| K243780 | 2025-02-07 |
| K230373 | 2023-05-22 |
| K223588 | 2023-01-26 |
| K212663 | 2022-06-09 |
| K212573 | 2021-12-08 |
| K203491 | 2021-04-07 |
| K191501 | 2020-01-03 |
| K183392 | 2019-01-04 |
| K182045 | 2018-12-27 |
| K172639 | 2017-11-03 |
| K152856 | 2016-06-02 |
| K083253 | 2009-05-15 |
| K083203 | 2009-04-28 |
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.