Mobile Laser Unit

GUDID 17340007000017

Clinical Laserthermia Systems AB

General/multiple surgical diode laser system
Primary Device ID17340007000017
NIH Device Record Keya5241aeb-6483-4121-9c07-809b8fc8a139
Commercial Distribution StatusIn Commercial Distribution
Brand NameMobile Laser Unit
Version Model Number1001-01
Company DUNS774856749
Company NameClinical Laserthermia Systems AB
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
GS117340007000017 [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 Date2016-09-18

On-Brand Devices [Mobile Laser Unit]

173400070000171001-01
173400070008261001-N2
173400070006111001-02

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