SS FiberLase™ Accessory Starter Kit with FiberLase

GUDID 07290109142517

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109142517
NIH Device Record Key255003d1-af48-4b92-a9ba-d91842f430f0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSS FiberLase™ Accessory Starter Kit with FiberLase
Version Model NumberSS FiberLase™ Accessory Starter Kit with FiberLase
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
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
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
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx
Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142517 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


[07290109142517]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-14

Devices Manufactured by LUMENIS LTD.

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07290109147192 - Lumenis Pulse 120H2025-02-26
07290109147208 - Lumenis Pulse, Moses 2.0 (INT)2025-02-26
07290109147215 - Lumenis Pulse 120H2025-02-26
07290109147222 - Lumenis Pulse 120H2025-02-26
07290109147291 - Lumenis Pulse 120H2025-02-26

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