FDA.reportPublic FDA data

Hyperblue plus

Primary DI
08033945934347
Brand
Hyperblue plus
Company
QUANTA SYSTEM SPA
Model
PDMS00246
Published
2016-08-18
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
ILYLamp, Infrared, Therapeutic Heating
PDZLasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2
PDZLasers For Temporary Increase Of Clear Nail In Patients With OnychomycosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033945934347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033945934347080339459343478033945934347

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical diode laser systemAn electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.

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
08059173390960Litho EVOPVMS000582020-01-27
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07090072490000FlexBeamRecharge Health ASILY2026-10-15
00840456400814MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456400821MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401293MOSES RaydarLUMENIS LTD.GEX2026-10-13
00840456401309MOSES RaydarLUMENIS LTD.GEX2026-10-13
B17731226455L0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-10-08
B17700100852TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
B17700100853TSS0Accu-BeamTRANSAMERICAN TECHNOLOGIES INTERNATIONALGEX2026-09-30
00850012528630ILYEO bodyJoylux, Inc.ILY2026-09-29
00850061407221LS Pro SystemsWELLNESS WITHOUT LIMITS LLCILY2026-09-24
06970453310015MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310084MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06970453310114MONALIZABeijing Sincoheren S&T Development Co.,Ltd.GEX2026-09-24
06971679500105LED Therapy DeviceBeijing Nubway S&T Co., Ltd.GEX2026-09-24
06974958310594mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310600mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310617mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06974958310624mitoredlightShenzhen Idea Light LimitedILY2026-09-21
06979994630002CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630019CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630026CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630033CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
06979994630040CuraBeamCuraBeam Medical Technology Co.,Ltd.ILY2026-08-26
08800190200004OLIZLTBIO Co., Ltd.ILY2026-08-26
06977782490029QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
06977782490036QuasarMDNingbo Jinhui Photoelectricity Technology Co., LtdILY2026-08-22
B5171301410Energy Flo TDP Heat LampAcu MarketILY2026-08-21
06970745912927ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912934ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17
06970745912996ApolomedShanghai Apolo Medical Technology Co.,LtdGEX2026-08-17