Mobile Laser Unit

GUDID 17340007000611

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system
Primary Device ID17340007000611
NIH Device Record Key9e957ecf-d900-4eb6-8629-28d6511f8262
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobile Laser Unit
Version Model Number1001-02
Company DUNS774856749
Company NameClinical Laserthermia Systems AB
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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
GS117340007000611 [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 Date2022-11-07
Device Publish Date2022-10-28

On-Brand Devices [Mobile Laser Unit]

173400070000171001-01
173400070008261001-N2
173400070006111001-02

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