YellowStar— 510(k) K261094
Substantially EquivalentAsclepion Laser Technologies GmbH
FDA 510(k) clearance K261094 for YellowStar, Substantially Equivalent on 2026-04-29. Applicant: Asclepion Laser Technologies GmbH. Device class: 2.
Summary
Asclepion Laser Technologies' YellowStar is filed under product code GEX (Powered Laser Surgical Instrument). The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Special 510(k).
Asclepion Laser Technologies filed from Jena, Germany. The decision came 27 calendar days after FDA received it (April 2 to April 29, 2026).
Clearance details
- Applicant
- Asclepion Laser Technologies GmbH
- Product code
- Product code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Jena, DE
Recent devices under product code GEX
view allMore clearances from Asclepion Laser Technologies GmbH
view allAdverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.