510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Asclepion Laser Technologies GmbH

Jena Thuringia, DE

Asclepion Laser Technologies GmbH appears in FDA device records in Jena Thuringia, DE. FDA records list 29 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
29
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 29 510(k) clearances for Asclepion Laser Technologies GmbH between 2004 and 2026. The busiest year on record is 2006, with 4. The most recent is 2026, with 1.

Clearances by year, as a table
510(k) clearance decisions for Asclepion Laser Technologies GmbH, by decision year
YearClearances
20041
20051
20064
20071
20091
20111
20122
20143
20154
20171
20201
20222
20231
20244
20251
20261
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K261094YellowStarGEXSubstantially Equivalent
K253100MultiPulse TFLGEXSubstantially Equivalent
K240831MultiCut SoloGCJSubstantially Equivalent
K241600DermablateGEXSubstantially Equivalent
K240816MeDioStarGEXSubstantially Equivalent
K231876MultiPulse HoPLUSGEXSubstantially Equivalent
K213597MultiCut SoloGCJSubstantially Equivalent
K213889PicoStarGEXSubstantially Equivalent
K210634MCL 31 Dermablate SystemGEXSubstantially Equivalent
K192483MeDioStarGEXSubstantially Equivalent
K161257MultiPulse HoPLUSGEXSubstantially Equivalent
K152153MicroSpot HandpieceGEXSubstantially Equivalent
K150140MCL 31 DermablateGEXSubstantially Equivalent
K143519The MeDioStar NeXT FamilyGEXSubstantially Equivalent
K133891MULTIPULSE TM+1470GEXSubstantially Equivalent
K131987MULTIPULSE HOPLUSGEXSubstantially Equivalent
K131757TATTOOSTAR EFFECT COMBOGEXSubstantially Equivalent
K133297QUADROSTARPROGREEN, QUADROSTARPROYELLOWGEXSubstantially Equivalent
K113489ORIONGEXSubstantially Equivalent
K112669TATTOOSTAR EFFECT YGEXSubstantially Equivalent
K111851MEDIOSTAR NEXTGEXSubstantially Equivalent
K081541DERMABLATE EFFECTGEXSubstantially Equivalent
K071451TATTOOSTAR YGEXSubstantially Equivalent
K060787TATTOOSTAR FAMILYGEXSubstantially Equivalent
K060459QUADROSTAR 980GEXSubstantially Equivalent
K060457QUADROSTAR 532GEXSubstantially Equivalent
K060455MULTISTARGEXSubstantially Equivalent
K050900MEDIOSTAR XTGEXSubstantially Equivalent
K042968MCL 30 DERMABLATE ER:YAG LASER SYSTEMGEXSubstantially Equivalent

Registered establishments

FDA registered establishments for Asclepion Laser Technologies GmbH, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30044851663004485166Asclepion Laser Technologies GmbHBruesseler Str. 10, Jena Thuringia 07747 DE2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain