FDA.reportPublic FDA data

LightSheer® Desire

Primary DI
07290109140384
Brand
LightSheer® Desire
Company
LUMENIS LTD.
Model
LightSheer Desire
Published
2016-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
07290109140384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290109140384072901091403847290109140384

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
408-764-3000xxx@xxx.xxx

Regulatory Flags#

DUNS number
600166524
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290109140629Aspiration TubeAspiration Tube2016-08-23
07290109141923MicroSlad™ micromanipulator side-entry portMicroSlad™ micromanipulator side-entry portAA50511002016-08-30
07290109143170Moses™AC-10030100AC-100301002016-11-02
07290109143408Moses™Moses™ 365 DFLAC-100301102016-11-02
07290109143453Moses™Moses™ 550 DFLAC-100301202016-11-02
07290109140674VersaCut Control UnitVersaCut Tissue Morcellator Control Unit2016-08-23
07290109140193Slimline EZ SIS 200 FiberSlimline EZ SIS 200 Fiber2016-08-22
07290109140209Slimline EZ SIS 365 FiberSlimline EZ SIS 365 Fiber2016-08-22
07290109140216Slimline EZ SIS 550 FiberSlimline EZ SIS 550 Fiber2016-08-22
07290109140223Slimline SIS 200 FiberSlimline SIS 200 Fiber2016-08-22
07290109140230Slimline SIS 365 FiberSlimline SIS 365 Fiber2016-08-22
07290109140247Slimline SIS 550 FiberSlimline SIS 550 Fiber2016-08-22
07290109140254Slimline SIS 1000 FiberSlimline SIS 1000 Fiber2016-08-22
07290109140261Slimline™ 200 D/F/LSlimline 200 DFL FiberAC-10016352016-08-22
07290109140278Xpeeda DSL FiberXpeeda DSL FiberAC-10007292016-08-22
07290109141527AcuPulse™ Incisional Handpiece 125 mm AcuPulse™ Incisional Handpiece 125 mm AA06326002016-08-28
07290109142203SurgiTouch™ Scannerkit for AcuPulse and AcuPulse DUOKT-10001002016-08-30
07290109145662SlimLine™SlimLine™ SIS EZ 5500644-020-012022-07-25
07290109141879AcuSpotAcuSpot 712 Micromanipulator AA26300002016-09-13
07290109141916AcuSpotAcuSpot 712 L Micromanipulator AA30420002016-09-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
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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
00851842007623LightScalpelLightscalpel, LLCGEX2023-06-26
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
08059173390724Single Use Sterile Surgical Optical Fiber QUANTA SYSTEM SPAGEX2020-05-27
08059173390755Single 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
08059173390021Youlaser CO2QUANTA SYSTEM SPAGEX2019-01-07