Picowon

Wontech Co., Ltd.

Country / region:Korea, Republic of (KR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K201406
Device name
Picowon
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-05-28
Decision date
2020-07-22
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The Picowon is indicated for tattoo and benign pigmented lesions removal.

Intended Use

The Picowon is indicated for tattoo and benign pigmented lesions removal.

Device Description

The Picowon laser system is an Alexandrite laser system. The Picowon laser system consists of an Alexandrite laser head, a power supply, a cooling system, a delivery system and other electrical components. The laser head contains Alexandrite laser medium, and two high-intensity xenon flash lamps enclosed together into the water cooling housing and two reflected mirrors fixed, in the special adjustable holders composed the laser cavity. The laser energies generated by the medium of Alexandrite is converted to the heat energy once it gets to human skin surface and used for tattoos and benign pigmented lesions removal. The combination of wavelength, pulse duration and energy fluence are disrupting the tattoo dye or pigment particles under the skin without harming the surrounding tissue. The fragmented dye or pigment particles eventually surface and fade as the epidermal layer or the skin is renewed. The system delivers laser energy at a wavelength of 755 nm. The output of the laser is delivered to the treatment area through an articulated Arm with a handpiece. A trigger (Foot Switch) controls the delivery of pulses. The user selects and sets the treatment parameters and other functions operated by software on the graphical user interface.

Summary parsed at:2026-06-01 05:48:13 UTC

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