RESURFX 1565NM LASER MODULE

Powered Laser Surgical Instrument With Microbeam\fractional Output

LUMENIS, LTD.

The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Resurfx 1565nm Laser Module.

Pre-market Notification Details

Device IDK130028
510k NumberK130028
Device Name:RESURFX 1565NM LASER MODULE
ClassificationPowered Laser Surgical Instrument With Microbeam\fractional Output
Applicant LUMENIS, LTD. 31 HAAVODA ST. Binyamina,  IL 30500
ContactYoram Levy
CorrespondentYoram Levy
LUMENIS, LTD. 31 HAAVODA ST. Binyamina,  IL 30500
Product CodeONG  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-01-03
Decision Date2013-09-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109143040 K130028 000
07290109140377 K130028 000

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