AcuPulse™ Upgrade Kit 40 to 40AES-A

GUDID 07290109142883

Additional DM UDI: 07290109144054; 07290109144061; 07290109144047; 07290109144122

LUMENIS LTD.

General/multiple surgical solid-state/carbon dioxide laser system
Primary Device ID07290109142883
NIH Device Record Keyc903dc9b-03cf-47d5-baad-f633f2f81426
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcuPulse™ Upgrade Kit 40 to 40AES-A
Version Model NumberAcuPulse™ Upgrade Kit 40 to 40AES-A
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109142883 [Primary]
GS107290109144078 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07290109142883]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-27
Device Publish Date2016-09-19

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 [AcuPulse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ACUPULSE
ACUPULSE
85331090 4080128 Dead/Cancelled
ACUPOLL RESEARCH, INC.
2011-05-26
ACUPULSE
ACUPULSE
75663817 2332207 Dead/Cancelled
AcuPOLL Precision Research
1999-03-19
ACUPULSE
ACUPULSE
74541836 not registered Dead/Abandoned
Acunetics Corporation
1994-06-24

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