PicoLO Premium Body
The PicoLO Premium body is the main unit of a pulsed Nd:YAG laser system used in dermatology. It contains processor-controlled laser sources operating at 1,064 nm and 532 nm. With…
The PicoLO Premium body is the main unit of a pulsed Nd:YAG laser system used in dermatology. It contains processor-controlled laser sources operating at 1,064 nm and 532 nm. With compatible delivery equipment, the system is used for tattoo removal and specified pigmented lesion, scar and wrinkle treatments.
The main unit works with a color touchscreen, articulated arm, handpiece and footswitch. The clinician selects treatment parameters on the touchscreen and activates emission with the footswitch. An internal water-to-air heat exchanger cools the system.
Treatment Configuration
The applicable handpiece, wavelength and patient skin type determine the treatment indication. Tattoo removal at 1,064 nm covers Fitzpatrick types I to VI, while 532 nm tattoo removal is limited to types I to III. The body requires the compatible delivery components.
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) | K212573 |
| Record published | 2022-01-06 |
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 |
| Packaging | Carton box, wooden box |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PicoLO Premium Body | 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.