PICOPLUS Laser System

Lutronic Corporation

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

2

Cited as predicate

2

Device details

FDA 510(k) registration fields

K number
K173700
Device name
PICOPLUS Laser System
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-12-04
Decision date
2018-06-19
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:

The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
- Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for:
- Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.
- Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV.

The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI.
- Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI.

The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for:
- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.
- Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III.

Intended Use

The PICOPLUS Laser System is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows: The 1064 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. The 532 nm wavelength and 450 pico-second pulse width of the PICOPLUS system is indicated for: Removal of tattoos for Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. Treatment of benign pigmented lesions removal for Fitzpatrick Skin Types I-IV. The 1064 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: Treatment of benign pigmented lesions on Fitzpatrick skin type I-VI. Removal of dark and multi-colored tattoos containing dark colored tattoo inks on Fitzpatrick skin types I-VI. The 532 nm wavelength and nanosecond pulse width of the PICOPLUS system is indicated for: Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. Removal of lighter colored tattoo inks, including red and yellow inks, on Fitzpatrick skin types I-III.

Device Description

The PICOPLUS Laser System is a surgical laser instrument for cutaneous laser treatment. The PICOPLUS Laser System is designed and manufactured in accordance with 21 CFR 820 (with emphasis on 820.30) and 21 CFR 1040 for medical devices in order to ensure user safety and durability of use. The PICOPLUS Laser System is a laser system, delivering energy at wavelengths of 1064 nm and 532 nm, both at pulse durations of 450 picoseconds (ps) and 2 nanoseconds (ns). The laser system is comprised of a system console, an articulated arm and attached handpieces.

Summary parsed at:2026-06-01 05:56:41 UTC

Predicate devices

2

K173700 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K173700 as a predicate