Selecta II

GUDID 07290109143231

LUMENIS INC.

General/multiple surgical frequency-doubled solid-state laser system
Primary Device ID07290109143231
NIH Device Record Key63d08fcc-e8e3-4537-aeb3-80fadc9123c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameSelecta II
Version Model NumberSelecta II
Company DUNS043618763
Company NameLUMENIS INC.
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109143231 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-08-23

Devices Manufactured by LUMENIS INC.

07290109140612 - Smart LIO2023-06-22
07290109143835 - Smart LIO2023-06-22
07290109143842 - Smart LIO2023-06-22
07290109143637 - Smart-V Illumination Add-on2022-03-31
07290109145181 - Digital Duet2021-03-30
17290109140787 - Acculite EndoOcular2020-02-24
07290109140827 - Acculite EndoOto2020-02-24
17290109140831 - Acculite EndoOto2020-02-24

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