# Asclepion Laser Technologies GmbH

- Location (FDA's records): Jena, DE
- FDA decisions: 29 (2004–2026): 29 510(k) clearances
- Product codes: GEX (27), GCJ (2)
- 510(k) review time since 2016: median 185 days, against 90 for FDA's reviews in the same codes and years (5 of 11 faster)
- Predicates its devices cite: 38 (18 its own); citations of its devices by later devices: 44 (18 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumenis, Inc.: 6 (https://510kreport.com/company/lumenis)
- Fotona D.D.: 3 (https://510kreport.com/company/fotona-dd)
- Quanta System Spa: 2 (https://510kreport.com/company/quanta-system)
- Starmedtec GmbH: 1 (https://510kreport.com/company/starmedtec)
- Trimedyne, Inc.: 1 (https://510kreport.com/company/trimedyne)
- Asclepion-Meditec AG: 1 (https://510kreport.com/company/asclepion-meditec)
- Richard Wolf Medical Instruments Corp.: 1 (https://510kreport.com/company/richard-wolf-medical-instruments)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)

## Firms that cite its devices most
- Quanta System Spa: 6 (https://510kreport.com/company/quanta-system)
- Gme German Medical Engineering GmbH: 2 (https://510kreport.com/company/gme-german-medical-engineering)
- El.En S.P.A.: 2 (https://510kreport.com/company/el-en)
- Storz Medical AG: 2 (https://510kreport.com/company/storz-medical)
- BTL Industries, Inc.: 2 (https://510kreport.com/company/btl-industries)
- Rhein Laser Technologies Co., Ltd.: 2 (https://510kreport.com/company/rhein-laser-technologies)
- Inmode MD, Ltd.: 1 (https://510kreport.com/company/inmode-md)
- Fotona D.D.: 1 (https://510kreport.com/company/fotona-dd)

## Its most-cited devices
- K081541: Dermablate Effect (2009), cited by 6
- K150140: MCL 31 Dermablate (2015), cited by 5
- K133297: Quadrostarprogreen, Quadrostarproyellow (2014), cited by 4
- K143519: The MeDioStar NeXT Family (2015), cited by 4
- K210634: MCL 31 Dermablate System (2022), cited by 3
- K133891: Multipulse TM+1470 (2015), cited by 3

## Recent decisions
- K261094: YellowStar (Apr 29, 2026)
- K253100: MultiPulse TFL (Oct 23, 2025)
- K240831: MultiCut Solo (Nov 6, 2024)
- K241600: Dermablate (Jul 3, 2024)
- K240816: MeDioStar (Apr 23, 2024)
- K231876: MultiPulse HoPLUS (Feb 22, 2024)
- K213597: MultiCut Solo (Jan 18, 2023)
- K213889: PicoStar (Apr 22, 2022)

Source page: https://510kreport.com/company/asclepion-laser-technologies