PicoLO Nd:YAG Picosecond Laser System

Laseroptek 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

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Device details

FDA 510(k) registration fields

K number
K183392
Device name
PicoLO Nd:YAG Picosecond Laser System
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2018-12-07
Decision date
2019-01-04
Submission type
Traditional
Technology type
Nd:YAG(AI inferred)
Clinical applications
Pigment treatmentSurgical cutting
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. The PicoWay laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The Resolve handpiece (1064 nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. The Resolve handpieces are also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Intended Use

PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064nm wavelength of the PicoLO laser system is indicated for tattoo removal for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. The 532nm wavelength of the PicoLO laser system is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.

Device Description

The PicoLO laser system is a multi-wavelength, pulsed laser system designed for the treatment of benign pigmented lesions. A key feature of the device is its ability to produce multiple laser wavelengths (1064 nm and 532 nm). The PicoLO Nd:YAG Picosecond Laser System consists of a set of Q-switched Nd:YAG lasers, controlled by an embedded processor, to be used in dermatology. The laser system uses focusing optics to deliver a pattern of thermal energy to the epidermis and dermis. This system consists of main body, color touch screen, articulated arm, hand piece and foot switch.

Summary parsed at:2026-06-01 05:54:55 UTC

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