Manufacturer
Wontech Co., Ltd.Picocare Family
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K181272
- Device name
- Picocare Family
- 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
- 2018-05-14
- Decision date
- 2018-07-31
- Submission type
- Special
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The Picocare Family is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064nm The 1064nm wavelength of the Picocare Family system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). 532nm The 532nm wavelength of the Picocare Family system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Intended Use
The Picocare Family is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064 nm wavelength of the Picocare Family system is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). The 532 nm wavelength of the Picocare Family system is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
Device Description
The Picocare Family is the solid state laser capable of delivering energy at wavelengths of 1,064 nm or 532 nm at short durations of 450 ps (picoseconds). 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.
Summary parsed at:2026-06-01 05:57:35 UTC
Predicate devices
2PicoWay Laser System
Picocare
K181272 references 2 predicate/reference devices
Cited as predicate
4PicoLazer Laser System
Picocaremajesty
PICOANDY (Q-Switched Nd:YAG Laser)
Picosecond Nd:YAG Laser (PICOCAREMAJESTY)
4 submissions cite K181272 as a predicate
