FDA.reportPublic FDA data

UltraPulse® α

Primary DI
07290117770047
Brand
UltraPulse® α
Company
LUMENIS BE LTD
Model
OR
Published
2022-08-01
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117770047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117770047072901177700477290117770047

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical carbon dioxide laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite carbon dioxide (CO2) to emit a high-power laser beam intended to incise, excise, ablate, vaporize and coagulate soft tissues across multiple clinical specialties (e.g., dermatological, gynaecological, ENT) using both ablative and non-ablative lasing; it is not dedicated to a specific specialty. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It does not include a therapeutic solid-state or diode laser.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600763501
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290117772737Multi-Spot™ Nd:YAG HeadNA2025-12-21
07290117772744M22™ Q-Switched HeadNA2025-12-21
07290117772751Stellar M22™ Multi-Spot™ Nd:YAG Upgrade kitNA2025-12-21
07290117772768Stellar M22™ Q-Switched Nd:YAG Upgrade KitNA2025-12-21
07290117772645Black Stellar XPL HPNA2025-09-08
07290117772652Stellar XPL Module KitNA2025-09-08
07290117772447FoLiCool™ TipNA2024-03-17
07290117772522FoLix™NA2024-03-17
07290117772539FoLix™ HandpieceNA2024-03-17
07290117772393LUSTER SystemNA2024-01-22
07290117772409LUSTER HandpieceNA2024-01-22
07290117772416LUSTER Tip, RoundNA2024-01-22
07290117771037LightSheer Duet, with ET and HS HandpiecesNA2023-06-22
07290117771068LightSheer Desire LightNA2023-06-22
07290117771082LightSheer Desire, BasicNA2023-06-22
07290117771044LightSheer® Duet ET™ HandpieceNA2023-03-22
07290117771051LightSheer® Duet HS™ HandpieceNA2023-03-22
17290117772420OPT™ ShieldsNA2023-12-26
17290117771829DeepFX Disposable TipsNA2023-12-04
17290117771836DeepFX Air Disposable TipsNA2023-12-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07898672790823Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-12
08056389701122EPI-C PLUSESPANSIONE MARKETING SPAGEX2026-04-30
08034108513317DEKA LUXEA PLUSDEKA M.E.L.A. SRLGEX2025-12-16
08052049500326Splendor XBIOS SRLGEX2025-01-16
08052049500333Splendor XBIOS SRLGEX2025-01-16
08052049500340Splendor XBIOS SRLGEX2025-01-16
08052049500357Splendor XBIOS SRLGEX2025-01-16
08057017760733DEKA TRUISTEL.EN. SPAGEX2023-04-27
08059173390243Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390274Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390304Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390335Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390366Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390397Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08059173390427Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-08-25
08059173390458Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-08-25
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
08059173391882Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391912Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2021-03-17
08059173391196Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2020-06-09
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390786Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08057017760429DEKA LUXEAEL.EN. SPAGEX2020-01-15
08056389700071E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08056389700088E-LIGHT LINEESPANSIONE MARKETING SPAGEX2019-09-03
08057017760276DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760283DEKA SMARTXIDE²EL.EN. SPAGEX2019-03-15
08057017760344DEKA MOTUS AYEL.EN. SPAGEX2019-03-15