UltraPulse® α

GUDID 07290109145143

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
Primary Device ID07290109145143
NIH Device Record Key50074f5e-6378-4cba-8a8f-f07987c8a652
Commercial Distribution StatusIn Commercial Distribution
Brand NameUltraPulse® α
Version Model NumberOffice
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109145143 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-10
Device Publish Date2021-08-02

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

Trademark Results [UltraPulse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ULTRAPULSE
ULTRAPULSE
88311112 5834862 Live/Registered
Lumenis Ltd.
2019-02-21
ULTRAPULSE
ULTRAPULSE
77079596 not registered Dead/Abandoned
Ultralife Batteries, Inc.
2007-01-10
ULTRAPULSE
ULTRAPULSE
75200356 not registered Dead/Abandoned
Barrett Holding LLC
1996-11-15
ULTRAPULSE
ULTRAPULSE
74730598 1993577 Dead/Cancelled
GPX CORP.
1995-09-18
ULTRAPULSE
ULTRAPULSE
74108037 1726659 Dead/Cancelled
LUMENIS, LTD.
1990-10-22
ULTRAPULSE
ULTRAPULSE
73226819 1189745 Dead/Cancelled
Sanex Chemicals Limited
1980-11-05
ULTRAPULSE
ULTRAPULSE
73019961 1000073 Dead/Expired
UNION CARBIDE CORPORATION
1974-04-26

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