FemTouch™ Standard Focus Tip

GUDID 07290109144955

Additional DM UDI: 07290109144986; 07290109144993;

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109144955
NIH Device Record Key849e6080-7a17-43dd-bfc6-535f9ab29671
Commercial Distribution StatusIn Commercial Distribution
Brand NameFemTouch™ Standard Focus Tip
Version Model NumberFemTouch™ Standard Focus Tip
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 Kitfalse
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

Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
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Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109144955 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


[07290109144955]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-14
Device Publish Date2020-10-06

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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

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