PicoStar

Asclepion Laser Technologies GmbH

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K213889
Device name
PicoStar
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-12-13
Decision date
2022-04-22
Submission type
Traditional
Technology type
Picosecond(AI inferred)
Clinical applications
Pigment treatment
Primary application
Pigment treatment
Classification source
AI classified

Indications for Use

The PicoStar laser system is indicated for the following at the specified wavelength:

532 nm:
- Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.

1064 nm:
- Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple.
- Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV.
- Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV.
- Only with microspot handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Intended Use

The PicoStar laser system is indicated for the following at the specified wavelength:

532 nm:
Removal of tattoos for Fitzpatrick skin types I-III to treat the following tattoo colors: red, yellow and orange. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-III.

1064 nm:
Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple. Indicated for benign pigmented lesions removal for Fitzpatrick skin types I-IV. Only with microspot handpiece, indicated for treatment of wrinkles in Fitzpatrick Skin Types I-IV. Only with microspot handpiece, indicated for the treatment of acne scars in Fitzpatrick Skin Types II-V.

Device Description

PicoStar is a solid state laser capable of delivering energy at wavelengths of 1064 nm, or 532 nm at short durations of max 400 picoseconds (ps) and repetition rates up to 10 Hz. The device system is composed of a system console, an articulated arm, and attached delivery handpieces (full spot or microspot). The laser output at each wavelength is delivered to the skin through an articulated arm delivery system terminated by a handpiece. The PicoStar is controlled via a touch screen display housed in the front of the device. The control panel enables the user to select the desired energy density level and repetition rate. Emission is triggered by means of a footswitch.

Summary parsed at:2026-06-01 05:39:17 UTC

Predicate devices

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No later 510(k)s cite this device yet

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