FDA.reportPublic FDA data

Ellex

Primary DI
09342395000588
Brand
Ellex
Company
ELLEX MEDICAL PTY LTD
Model
6328990
Device description
ACC. SPECTACLES, SAFETY, 523nm & 1064nm (TANGO)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
HQFLaser, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
HQFLaser, OphthalmicOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K021550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K021550000LUMENIS SELECTA DUETEllex Medical Pty, Ltd.2002-08-09GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09342395000588PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09342395000588093423950005889342395000588

GMDN Terms#

Term, Definition table
TermDefinition
Laser beam eye protector, patientA protective device that is designed to be placed either under or over the patient's eyelids in order to protect the eyes from injury during laser surgery.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
999-999-9999xxx@xx.xx

Regulatory Flags#

DUNS number
756138509
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09342395000106Integre Pro Red/GreenLP1RG2016-09-24
09342395000502EllexTS_ACCESS2023-06-09
09342395000519EllexTS_ACCESS-MOBILE2023-06-09
09342395000526EllexTS_MOBILE2023-06-09
09342395000540EllexCOLUMN_HV2023-06-09
09342395000557EllexCOLUMN_LV2023-06-09
0934239500227840MHZKIT-USA40MHZ ACCESSORY KIT-USA2024-11-26
09342395002285ACC0004240MHz Probe International Accessory Kit2024-11-26
09342395001370Eye Cubed V4 New GenI3 SYSTEM-ABDU2016-09-24
09342395000038UltraQ ReflexLQP3106-U2016-09-24
09342395000175Solitaire LP45322016-09-23
09342395000199SOLITAIRE LP45322016-09-24
09342395000069SoloLT5106-S2016-09-24
09342395000113TangoLT5106-T2016-09-23
09342395000137UltraQLQP3106-U 2016-09-24
093423950002122RTLR15322016-09-24
09342395000090Integre ProLP55322016-09-24
09342395000120Integre Pro YellowLP5612016-09-24
09342395000144Integre Pro Scan Red-GreenLP6RG2016-03-02
09342395000151Integre Pro Scan Red-YellowLP6RY2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G866REACTLT0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
G866REACTPRO0LIGHTWAVEMedAesthetics International LLCGEX2026-06-08
00075020120335Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
00075020120410Philips Lumea IPLPhilips Consumer Lifestyle B.V.GEX2026-06-05
06974077940016MLKJWeifang Mingliang Electronics Co., Ltd.GEX2026-05-27
07898672792193Medical SanMEDICAL SAN INDUSTRIA DE EQUIPAMENTOS MEDICOS LTDAGEX2026-05-27
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
08033945937645Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2022-04-06
08033945939052Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2022-04-06
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
08033945938413Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938420Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938437Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938444Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938468Single use Surgical Optical FiberQUANTA SYSTEM SPAGEX2018-09-28
08033945938475Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2018-09-28
08033945938482Reusable Surgical Optical Fiber QUANTA SYSTEM SPAGEX2018-09-28