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Data / Medical devices / Germany / Asclepion Laser Technologies GmbH

Asclepion Laser Technologies GmbH: FDA-registered device maker in Jena Thuringia, Germany, 14 510(k) clearances

Asclepion Laser Technologies GmbH is registered with the FDA (registration 3004485166) in Jena Thuringia, Germany. It lists 2 device types. The FDA files 14 510(k) clearances under its listings, the newest dated April 29, 2026. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Asclepion Laser Technologies GmbH
FDA registration number
3004485166
Address
Bruesseler Str. 10, Jena Thuringia, Germany, 07747
Owner or operator
Asclepion Laser Technologies GmbH (10023622)
Roles
Exporter to the US, Manufacturer, Specification developer
First device listed
December 5, 2007
Registered through
2026
Brand names listed
AlexStar, Dermablate, Juliet, MCL 31 Dermablate, MeDioStar, MultiCut Solo, MultiPulse Ho, MultiPulse HoPLUS and more

Devices it lists

DeviceProduct codeClassRoleSource
Laparoscope, General & Plastic SurgeryGCJ2Manufactureraccessdata.fda.gov
Powered Laser Surgical InstrumentGEX2Exporter to the US, Manufacturer, Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
April 29, 2026K261094YellowStarGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
October 23, 2025K253100MultiPulse TFLGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
November 6, 2024K240831MultiCut SoloGCJSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
July 3, 2024K241600DermablateGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
April 23, 2024K240816MeDioStarGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
February 22, 2024K231876MultiPulse HoPLUSGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
April 22, 2022K213889PicoStarGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
April 13, 2022K210634MCL 31 Dermablate SystemGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
September 17, 2019K191842Discovery Pico, Discovery Pico Plus, Discovery Pico DermGEXSubstantially EquivalentQuanta System Spaaccessdata.fda.gov
October 2, 2018K181867Deka Smartxide2 TrioGEXSubstantially EquivalentEl.En Electronic Engineering Spaaccessdata.fda.gov
June 23, 2017K163449HyPHo Laser SystemGEXSubstantially EquivalentHyper Photonics Srlaccessdata.fda.gov
January 30, 2015K133891MULTIPULSE TM+1470GEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
June 10, 2014K133297QUADROSTARPROGREEN, QUADROSTARPROYELLOWGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov
September 27, 2006K060787TATTOOSTAR FAMILYGEXSubstantially EquivalentAsclepion Laser Technologies GmbHaccessdata.fda.gov

Compare with other makers

Updated April 29, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.