Manufacturer
Asclepion Laser Technologies GmbHYellowStar
Asclepion Laser Technologies GmbH
Country / Region:Germany (DE)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K261094
- Device name
- YellowStar
- Country / Region
- Germany(DE)
- 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—
—
Not ingested
Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta)
K261094 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K261094 as a predicate