Manufacturer
Wontech Co., Ltd.Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K241144
- Device name
- Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
- Company
- Wontech Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-04-25
- Decision date
- 2024-06-24
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The PICOCAREMAJESTY is indicated for the following at the specified wavelength: * 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black, brown, green, blue and purple. * 532 nm: Removal of tattoos for Fitzpatrick skin types I - III to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
Intended Use
The PICOCAREMAJESTY is indicated for the following at the specified wavelength: * 1064 nm: Removal of tattoos for all skin types (Fitzpatrick I - VI) to treat the following tattoo colors: black, brown, green, blue and purple. * 532 nm: Removal of tattoos for Fitzpatrick skin types I - III to treat the following tattoo colors: red, yellow and orange. * Treatment of benign pigmented lesions for Fitzpatrick skin types I-IV.
Device Description
The PICOCAREMAJESTY is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, an articulated arm, a handpiece and a foot switch. The laser output is delivered to the skin through the articulated arm delivery system terminated by the handpiece. The fluence (energy density) and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. For treatment, the user can select the appropriate fluence value. (The treatment parameters recommended is provided in the user Manual) The energy is changed automatically in accordance with the selected fluence (down) button and then, the fluence is increased / decreased by 0.1 J/cm2. The selectable fluence values are 0.2 to 10.0 J/cm2 at 1064nm and 0.1 to 2.5 J/cm2 at 532nm.
Summary parsed at:2026-06-01 05:28:12 UTC
Predicate devices
4Picocare Family
PICOHI
Picocaremajesty
PICOANDY (Q-Switched Nd:YAG Laser)
K241144 references 4 predicate/reference devices
Cited as predicate
2Boston PICO (Boston PICO)
Picosecond Nd:YAG Laser Systems (Model: HS-298)
2 submissions cite K241144 as a predicate
