FiberLase™ HP-R 140 mm bent, straight tip

GUDID 07290109141152

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 laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable General/multiple surgical laser system beam guide, reusable
Primary Device ID07290109141152
NIH Device Record Key11b2d338-31b6-45c9-b45d-0d80d924bd33
Commercial Distribution StatusIn Commercial Distribution
Brand NameFiberLase™ HP-R 140 mm bent, straight tip
Version Model NumberFiberLase™ HP-R 140 mm bent, straight 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
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
GS107290109141152 [Primary]
GS107290109143828 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


[07290109141152]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-29
Device Publish Date2016-08-25

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07290109147062 - VersaPulse PowerSuite 80/100W2022-09-27

Trademark Results [FiberLase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FIBERLASE
FIBERLASE
74372304 1805940 Dead/Cancelled
Surgilase Inc.
1993-03-26
FIBERLASE
FIBERLASE
74343254 1789262 Dead/Cancelled
SHARPLAN LASERS, INC.
1992-12-23
FIBERLASE
FIBERLASE
73618737 not registered Dead/Abandoned
GENERAL FIBER OPTICS, INC.
1986-09-08
FIBERLASE
FIBERLASE
73403853 1300403 Dead/Cancelled
Barr & Stroud Limited
1982-11-23

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