Picocare Family, Picocare450
Picocare450 is a Q-switched Nd:YAG laser system for tattoo removal. Its 1064-nanometre wavelength treats dark inks in Fitzpatrick skin types I to VI. Its 532-nanometre wavelength treats…
Picocare450 is a Q-switched Nd:YAG laser system for tattoo removal. Its 1064-nanometre wavelength treats dark inks in Fitzpatrick skin types I to VI. Its 532-nanometre wavelength treats lighter inks, including red and yellow, in skin types I to III.
The main unit generates pulses lasting 450 picoseconds and sends the light through an articulated arm to a handpiece at the skin. A foot switch controls delivery, while the front touchscreen sets energy density and pulse frequency.
Display Feedback
The display shows system feedback, including the number of pulses delivered and the selected spot size. The system offers spot sizes from two to ten millimetres.
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 | Wontech Co., Ltd., 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) | K181272 |
| Record published | 2020-06-16 |
| Record revised | 2023-03-01 (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 |
|---|---|---|
| Picocare Family, Picocare450 | 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 |
|---|---|
| K252877 | 2025-12-19 |
| K250165 | 2025-07-03 |
| K251288 | 2025-05-14 |
| K251094 | 2025-05-06 |
| K243957 | 2025-03-12 |
| K241527 | 2025-02-14 |
| K241643 | 2025-02-14 |
| K241930 | 2024-11-14 |
| K241406 | 2024-06-28 |
| K241144 | 2024-06-24 |
| K234104 | 2024-03-15 |
| K232106 | 2024-01-08 |
| K223727 | 2023-08-25 |
| K231054 | 2023-08-14 |
| K221427 | 2022-08-24 |
| K212127 | 2022-01-07 |
| K201406 | 2020-07-22 |
| K200110 | 2020-03-16 |
| K183563 | 2019-09-05 |
| K183156 | 2019-04-24 |
| K181272 | 2018-07-31 |
| K162755 | 2017-06-12 |
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.