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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Asclepion Laser Technologies GmbH — Predicate Candidate Screening

29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

134 daysmedian FDA review time
406 days90th percentile
29clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K261094YellowStarAsclepion Laser Technologies GmbH2026-04-29270
K253100MultiPulse TFLAsclepion Laser Technologies GmbH2025-10-23290
K240831MultiCut SoloAsclepion Laser Technologies GmbH2024-11-062250
K241600DermablateAsclepion Laser Technologies GmbH2024-07-03290
K240816MeDioStarAsclepion Laser Technologies GmbH2024-04-23290
K231876MultiPulse HoPLUSAsclepion Laser Technologies GmbH2024-02-222410
K213597MultiCut SoloAsclepion Laser Technologies GmbH2023-01-184320
K213889PicoStarAsclepion Laser Technologies GmbH2022-04-221300
K210634MCL 31 Dermablate SystemAsclepion Laser Technologies GmbH2022-04-134060
K192483MeDioStarAsclepion Laser Technologies GmbH2020-03-131850
K161257MultiPulse HoPLUSAsclepion Laser Technologies GmbH2017-03-313310
K152153MicroSpot HandpieceAsclepion Laser Technologies GmbH2015-12-111300
K150140MCL 31 DermablateAsclepion Laser Technologies GmbH2015-06-051340
K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH2015-03-10880
K133891MULTIPULSE TM+1470Asclepion Laser Technologies GmbH2015-01-304060
K131987MULTIPULSE HOPLUSAsclepion Laser Technologies GmbH2014-10-154740
K131757TATTOOSTAR EFFECT COMBOAsclepion Laser Technologies GmbH2014-07-173950
K133297QUADROSTARPROGREEN, QUADROSTARPROYELLOWAsclepion Laser Technologies GmbH2014-06-102280
K113489ORIONAsclepion Laser Technologies GmbH2012-07-272470
K112669TATTOOSTAR EFFECT YAsclepion Laser Technologies GmbH2012-05-112400
K111851MEDIOSTAR NEXTAsclepion Laser Technologies GmbH2011-07-0890
K081541DERMABLATE EFFECTAsclepion Laser Technologies GmbH2009-02-232660
K071451TATTOOSTAR YAsclepion Laser Technologies GmbH2007-08-01690
K060787TATTOOSTAR FAMILYAsclepion Laser Technologies GmbH2006-09-271880
K060455MULTISTARAsclepion Laser Technologies GmbH2006-03-20260
K060457QUADROSTAR 532Asclepion Laser Technologies GmbH2006-03-20260
K060459QUADROSTAR 980Asclepion Laser Technologies GmbH2006-03-20260
K050900MEDIOSTAR XTAsclepion Laser Technologies GmbH2005-05-16350
K042968MCL 30 DERMABLATE ER:YAG LASER SYSTEMAsclepion Laser Technologies GmbH2004-11-24270

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda