FDA.reportPublic FDA data

Litho EVO

Primary DI
08059173390960
Brand
Litho EVO
Company
QUANTA SYSTEM SPA
Model
PVMS00058
Published
2020-01-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192990000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192990000Litho EvoQuanta System Spa2019-12-20GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08059173390960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08059173390960080591733909608059173390960

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
436045833
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08059173396573Single Use CO2 Laser fiberHAF8050012026-01-26
08059173396580Single Use CO2 Laser fiberHAF8050012026-01-26
08059173396535Levanta PlusPCMS003562025-11-27
08059173396474Karma PCMS003552023-12-13
08059173394494Youlaser PRIME MTPYMS000112025-11-05
08059173394500Youlaser PRIMEPYMS000122025-11-05
08059173394517Youlaser PRIME CO2PGMS000172025-11-05
08059173396481Optiscan PRIME OAM0018862025-11-05
08059173392186Litho EVOPVMS000642025-09-29
08059173393046Suprema VTPCMS005012023-02-13
08059173393053Duetto SupremaPCMS005022023-02-13
08059173393107Domino SupremaPCMS005072023-02-13
08059173392230Accure PFMS000042022-12-01
08033945936969Thunder PCMS004052017-08-04
08033945936976Thunder VTPCMS004062017-08-04
08033945936983 Thunder HRPCMS004072017-08-04
08033945937638585PDMS005802017-11-06
08033945938857DenaVePDMS002532018-06-08
08033945931490Quanta 1470PDMS001862016-08-18
08033945930080Polysurge 980-150PDMS001762016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16