Picocaremajesty
PICOCAREMAJESTY is a laser system for surgical and aesthetic applications in dermatology and general and plastic surgery. Its FDA filing identifies tattoo-removal uses for two wavelengths,…
PICOCAREMAJESTY is a laser system for surgical and aesthetic applications in dermatology and general and plastic surgery. Its FDA filing identifies tattoo-removal uses for two wavelengths, with permitted ink colors and skin-type ranges specified separately.
The 1064 nm wavelength is indicated for dark tattoo inks, including multicolored tattoos containing dark inks, across Fitzpatrick skin types I through VI. The 532 nm wavelength is indicated for lighter inks, including red and yellow, for skin types I through III.
Wavelength-Specific Indications
The indication ties dark tattoo inks and Fitzpatrick skin types I to VI to the 1064 nm wavelength, and lighter inks including red and yellow with skin types I to III to 532 nm.
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) | K212127 |
| Record published | 2022-02-01 |
| Record revised | 2024-07-03 (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 |
|---|---|---|
| PICOCAREMAJESTY | 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.