585

GUDID 08033945937638

QUANTA SYSTEM SPA

Dermatological solid-state laser system
Primary Device ID08033945937638
NIH Device Record Key536697cc-3778-49ab-a002-a627d7e77d6a
Commercial Distribution StatusIn Commercial Distribution
Brand Name585
Version Model NumberPDMS00580
Company DUNS436045833
Company NameQUANTA SYSTEM SPA
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
GS108033945937638 [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 Number6
Public Version Date2020-02-06
Device Publish Date2017-11-06

Devices Manufactured by QUANTA SYSTEM SPA

08059173396375 - Echo2024-07-01
08033945936938 - Laserlith I-dust 2024-05-23 Manufactured for Edap TMS
08059173396474 - Karma 2023-12-21
08059173396399 - Rosso2023-06-23
08059173396405 - Rosso2023-06-23
08033945934767 - Quantabella2023-06-16
08033945937492 - Litho 602023-06-16
08033945938369 - Litho 1002023-06-16

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