PICO-K

Speclipse, Inc.

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

0

Device details

FDA 510(k) registration fields

K number
K253342
Device name
PICO-K
Country / region
Korea, Republic of(KR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-09-30
Decision date
2025-12-24
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatmentAcne treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The PICO-K is intended for use in the following indications at the specified wavelength:

1064 nm wavelength
- Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
- Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
- Treatment of acne scars in Fitzpatrick Skin Types II-V
- Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV

532 nm wavelength
- Tattoo removal in Skin Types I - III
- Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV

Intended Use

The PICO-K is intended for use in the following indications at the specified wavelength: 1064 nm wavelength - Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple - Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV - Treatment of acne scars in Fitzpatrick Skin Types II-V - Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV; 532 nm wavelength - Tattoo removal in Skin Types I - III - Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV.

Device Description

The Nd:YAG laser surgical system employs a solid-state laser with a medium of Nd:YAG at 1064 nm and KTP at 532 nm. The system consists of a power supply, laser resonator, touch LCD monitor, articulated arm, handpieces, foot switch, and laser protective eyewear. The main body transmits the laser energy through the articulating arm to the handpiece which is positioned above or in contact with the treatment area. Three different handpieces can be attached to the articulated arm, the Zoom handpiece, Collimated handpiece, and MLA handpiece. Each handpiece integrates an aiming beam that shows the treatment area. The energy from the 1064 nm wavelengths emitted by the laser is directed at the cells or tissues of the skin, raising the temperature of the targeted tissue according to the Selective Photothermolysis Theory. This selective heating of the tissue results in the cutting, destruction, or removal of the tissue through the heat energy produced by the laser. PICO-K employs a patented resonator design with optics aligned under controlled thermal lensing conditions. At high repetition rates (8–10 Hz), thermal lensing of the Nd:YAG rod can degrade beam quality in conventional systems. In PICO-K, the lamp frequency is fixed at 8–10 Hz, optical alignment is optimized under these conditions, and laser emission is generated only at divisor frequencies (1, 2, 3, 4, 5, 8, 9, 10 Hz).

Summary parsed at:2026-06-01 05:24:39 UTC

Predicate devices

2

K253342 references 2 predicate/reference devices

Cited as predicate

0

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