Picocaremajesty
510(k) K212127
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK212127 | Date7 Jan 2022 | StatusActive |
Official records
- FDA 510(k) database K212127
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Wontech Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The Picocaremajesty is a laser device intended for use in general and plastic surgery. It utilizes picosecond technology to deliver energy for various dermatological and surgical applications.
This device is supplied by Wontech Co., Ltd. and has received FDA 510K clearance. It weighs 99 kg and is designed for professional clinical settings.
Devices cleared under K212127
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| PICOCAREMAJESTY | PICOCAREMAJESTY | 08800022305600 | — | On the market |
Similar devices
Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).
- CO2 Surgical Laser System by Niic U.S.A., Inc.
- Models 4000/6000/8000/8900 Laser for Derma/Surgery by Cooper Lasersonics, Inc.
- Hollywood Spectra Laser System by Lutronic Corporation
- Model 545-45 Laser for Derma., Pod., Surgical by Britt Corp., Inc.
- Diode Laser Hair Removal System by Shandong Huamei Technology Co., Ltd.
- Percudisc PLDD Delivery System/Procedure Kit by Percudisc, Inc.
- Model 1210 OmniPulse Holmium Laser System by TRIMEDYNE, INC.
- Fencer 308 Excimer Laser System by Kera Harvest/Laser Max Medical Technologies Corp
- Medilas H Laser Fibers by Dornier MedTech America, Inc.
- Ktp Disc Kit by Laserscope