Litho EVO

GUDID 08059173392186

QUANTA SYSTEM SPA

General/multiple surgical solid-state laser system
Primary Device ID08059173392186
NIH Device Record Keya124237f-9174-48aa-9e98-d61c50715daa
Commercial Distribution StatusIn Commercial Distribution
Brand NameLitho EVO
Version Model NumberPVMS00064
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
GS108059173392186 [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 Date2025-10-07
Device Publish Date2025-09-29

On-Brand Devices [Litho EVO]

08059173390960PVMS00058
08059173392186PVMS00064

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