VersaPulse PowerSuite RG0638-803-01

GUDID 07290109145860

LUMENIS LTD.

General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system General/multiple surgical solid-state laser system
Primary Device ID07290109145860
NIH Device Record Keya0c99bee-7b06-4a6d-b571-ccbeacfb3982
Commercial Distribution StatusIn Commercial Distribution
Brand NameVersaPulse PowerSuite
Version Model NumberVersaPulse PowerSuite 100W
Catalog NumberRG0638-803-01
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
GS107290109145860 [Primary]

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 Date2022-08-17
Device Publish Date2022-08-09

On-Brand Devices [VersaPulse PowerSuite]

07290109146232VersaPulse PowerSuite 60W
07290109146225VersaPulse Powersuite 80/100W
07290109146218VersaPulse PowerSuite 60W
07290109146195VersaPulse PowerSuite 100W
07290109146171VersaPulse PowerSuite 100W
07290109146164VersaPulse PowerSuite 80/100W
07290109145860VersaPulse PowerSuite 100W
07290109145853VersaPulse PowerSuite 100W

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.