FDA.reportPublic FDA data

Fixed Eye Safety Filter

Primary DI
00810096330291
Brand
Fixed Eye Safety Filter
Company
Lumenis Be, Inc.
Model
Fixed Eye Safety Filter 532 nm
Published
2023-04-02
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151109000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151109000Lumenis Smart532 Laser SystemLumenis, Inc.2015-10-30GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810096330291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096330291008100963302918100963302910810096330291

GMDN Terms#

Term, Definition table
TermDefinition
Laser filter, opticalAn eyepiece to an optical system, such as an endoscope, used during a laser procedure to protect the operator's eyes from laser energy transmitted through the optics. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118292380
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810096330246Endo kit with Fixed Eye Safety FilterEndo kit with Fixed ESF 532 nm2023-04-02
00810096330253Endo kit with Automatic Eye Safety FilterEndo kit with Auto ESF 532 nm2023-04-02
00810096330260Endo kit with Automatic Eye Safety FilterEndo kit with Auto 532/577/659 nm2023-04-02
00810096330277Endo kit with Fixed Eye Safety FilterEndo kit with Fixed 532/577/659 nm2023-04-02
00810096330284Automatic Eye Safety FilterAutomatic Eye Safety Filter 532nm2023-04-02
00810096330307Automatic Eye Safety FilterAutomatic Eye Safety Filter 532/577/659 nm2023-04-02
00810096330314Fixed Eye Safety FilterFixed Eye Safety Filter 532/577/659 nm2023-04-02
00810096330000Selecta Duet™Selecta Duet™2023-05-12
00810096330017Digital Duet™Digital Duet™2023-05-12
00810096330024Smart-V Illumination Add-onSmart-V Illumination Add-on2023-05-12
00810096330086Vision One G/Y/R2023-04-02
00810096330093Vision OneG/Y2023-04-02
00810096330109Vision OneGreen2023-04-02
00810096330116Vision One Red2023-04-02
00810096330123Vision OneG/R2023-04-02
00810096330130Vision One Y/R2023-04-02
00810096330147Vision OneYellow2023-04-02
00810096330062Smart532NA2023-04-02
00810096330079Array LaserLinkNA2023-04-02
00810096330215Smart LIONA2023-04-02

Other Devices Sharing Product Codes#

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