YellowStar

Asclepion Laser Technologies GmbH

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

Product code GEX· 21 CFR 878.4810

View Summary PDF

Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K261094
Device name
YellowStar
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2026-04-02
Decision date
2026-04-29
Submission type
Special
Technology type
Diode(AI inferred)
Clinical applications
Vascular treatmentPigment treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

YellowStar is intended for the treatment of benign vascular and benign pigmented lesions.

Intended Use

YellowStar is intended for the treatment of benign vascular and benign pigmented lesions.

Device Description

YellowStar device is equipped with a high-power optically pumped semiconductor laser (HOPSL). It is a class 4 laser product that emits relatively long pulses (> 2 ms) up to continuous emission. A frequency doubling crystal (SHG) generates 577nm at a maximum output power of 8W. The device can operate with either a focusing handpiece or with a scanner handpiece. The laser beam is transmitted from the device to the handpieces via a transfer fiber. YellowStar includes: Control system of the high-power diode laser; User interface, which allows the user to set all relevant parameters; Handpieces (applicators) and a transfer fiber to apply the laser radiation to the intended target; Foot switch to trigger laser emission; Delivery of radiation by optical fiber.

Summary parsed at:2026-06-01 05:19:31 UTC

Predicate devices

2

K261094 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K261094 as a predicate