Stellart M22 - ResurFX Upgrade

GUDID 07290109144764

LUMENIS LTD.

Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system Multi-modality skin surface treatment system
Primary Device ID07290109144764
NIH Device Record Key8a31cf2e-6683-4389-b1e6-bcbce172bc45
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellart M22 - ResurFX Upgrade
Version Model NumberStellart M22 - ResurFX Upgrade
Company DUNS600166524
Company NameLUMENIS LTD.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com
Phone+97249599000
Emailinfo@lumenis.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109144764 [Primary]

FDA Product Code

ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-01-20
Device Publish Date2019-08-06

Devices Manufactured by LUMENIS LTD.

07290118853701 - Lumenis Pulse 60H, 60Hz2023-12-18
07290109144924 - Stellar SapphireCool LG 6mm2023-08-16
07290109144931 - Stellar SapphireCool LG 15x352023-08-16
07290109144948 - Stellar SapphireCool LG 8x152023-08-16
07290109146676 - SurgiTouch Scanner 2022-09-30
07290109146133 - UltraPulse® DUO2022-09-28 UltraPulse DUO
07290109147055 - VersaPulse PowerSuite 80/100W2022-09-27
07290109147062 - VersaPulse PowerSuite 80/100W2022-09-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.