PicoLO Premium

Laseroptek Co., Ltd.

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

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
K212573
Device name
PicoLO Premium
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-08-16
Decision date
2021-12-08
Submission type
Special
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

PicoLO laser system is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery.

<Tattoo Mode>
1064nm
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.

532nm
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.

<PH Mode>
The PicoLO laser system is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.
The 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.
The PicoLO laser system is 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 Premium 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 Premium is indicated for tattoo removal for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. The PicoLO Premium is also indicated for benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The DIA FX 1064 handpiece (1064nm) is also indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V. PicoLO Premium is also indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.

Device Description

PicoLO Premium 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 Premium 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 05:43:40 UTC

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