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Picosecond Nd:YAG Laser System; PICO LEGEND

Ami, Inc.

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

Product code GEX· 21 CFR 878.4810

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Company

Ami, Inc.
Korea, Republic of (KR)

Product code

GEX
21 CFR 878.4810

Predicate devices

1
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Cited as predicate

3
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Device details

FDA 510(k) registration fields

K number
K233007
Device name
Picosecond Nd:YAG Laser System; PICO LEGEND
Company
Ami, Inc.
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-09-22
Decision date
2024-06-12
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 PICO LEGEND Nd:YAG 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 PICO LEGEND Nd:YAG Laser 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 532nm wavelength of the PICO LEGEND Nd:YAG Laser 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 PICO LEGEND Nd:YAG 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 PICO LEGEND Nd:YAG Laser 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 532nm wavelength of the PICO LEGEND Nd:YAG Laser System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.

Summary parsed at:2026-06-01 05:26:38 UTC

Predicate devices

1

K233007 references 1 predicate/reference device

Cited as predicate

3

3 submissions cite K233007 as a predicate