Slimline 200 Fiber

GUDID 07290109140001

LUMENIS LTD.

General/multiple surgical solid-state laser system
Primary Device ID07290109140001
NIH Device Record Key1e4248d1-89f3-468b-bf26-41e8c002c000
Commercial Distribution StatusIn Commercial Distribution
Brand NameSlimline 200 Fiber
Version Model NumberSlimline 200 Fiber
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


[07290109140001]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-21

Devices Manufactured by LUMENIS LTD.

07290109147161 - Lumenis Pulse 120H2025-02-26
07290109147178 - Lumenis Pulse 120H2025-02-26
07290109147185 - Lumenis Pulse, Moses 2.0 (DOM)2025-02-26
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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