UltraPulse Surgical And Aesthetic CO2 Laser System, Delivery Devices And Accessories

Powered Laser Surgical Instrument

Lumenis Ltd.

The following data is part of a premarket notification filed by Lumenis Ltd. with the FDA for Ultrapulse Surgical And Aesthetic Co2 Laser System, Delivery Devices And Accessories.

Pre-market Notification Details

Device IDK203544
510k NumberK203544
Device Name:UltraPulse Surgical And Aesthetic CO2 Laser System, Delivery Devices And Accessories
ClassificationPowered Laser Surgical Instrument
Applicant Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
ContactShlomit Segman
CorrespondentShlomit Segman
Lumenis Ltd. 6 Hakidma Street PO Box 240 Yokneam,  IL 2069204
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-04
Decision Date2020-12-24

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000
07290109145037 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109145037 K203544 000
07290109144511 K203544 000
07290109145068 K203544 000
07290109144245 K203544 000
07290109145044 K203544 000
07290109144511 K203544 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.