LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity

Powered Laser Surgical Instrument

Lumenis Ltd.

The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Lightsheer Desire; Lightsheer Desire Light; Lightsheer Duet; Lightsheer Infinity.

Pre-market Notification Details

Device IDK170179
510k NumberK170179
Device Name:LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
ClassificationPowered Laser Surgical Instrument
Applicant Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
ContactAmaya De Levie
CorrespondentAmaya De Levie
Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-19
Decision Date2017-09-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143132 K170179 000
07290117770061 K170179 000
07290117770078 K170179 000
07290117770085 K170179 000
07290117770092 K170179 000
07290117770108 K170179 000
07290117770733 K170179 000
07290117770115 K170179 000
07290117770122 K170179 000
07290117771037 K170179 000
07290117771068 K170179 000
07290117771075 K170179 000
07290117771082 K170179 000
07290117771044 K170179 000
07290117771051 K170179 000
07290109144658 K170179 000
07290109141589 K170179 000
07290109143125 K170179 000
07290117770030 K170179 000

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