Manufacturer
Ami, Inc.Picosecond Nd:YAG Laser System; PICO LEGEND
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
1Picocaremajesty
K233007 references 1 predicate/reference device
Cited as predicate
3Medical Picosecond ND: YAG Laser System (PZ-6)
Picosecond Laser Device (PF131-BI)
Picosecond laser device (BMPS4)
3 submissions cite K233007 as a predicate