MultiPulse HoPLUS

Powered Laser Surgical Instrument

ASCLEPION LASER TECHNOLOGIES GMBH

The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Multipulse Hoplus.

Pre-market Notification Details

Device IDK161257
510k NumberK161257
Device Name:MultiPulse HoPLUS
ClassificationPowered Laser Surgical Instrument
Applicant ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena,  DE 07747
ContactAntje Katzer
CorrespondentAntje Katzer
ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena,  DE 07747
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-05-04
Decision Date2017-03-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04058784000460 K161257 000
04058784000330 K161257 000
04058784000323 K161257 000
04058784000316 K161257 000
04058784000309 K161257 000
04058784000293 K161257 000
04058784001009 K161257 000
04058784000996 K161257 000
04058784001054 K161257 000
04058784000347 K161257 000
04058784000354 K161257 000
04058784000453 K161257 000
04058784000446 K161257 000
04058784000439 K161257 000
04058784000422 K161257 000
04058784000415 K161257 000
04058784000408 K161257 000
04058784000392 K161257 000
04058784000361 K161257 000
04058784001023 K161257 000

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