FDA.reportPublic FDA data

Vision One

Primary DI
00810096330093
Brand
Vision One
Company
Lumenis Be, Inc.
Model
G/Y
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
K111213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111213000VISION ONE LASER SYSTEMLumenis, Inc.2011-07-25GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810096330093PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810096330093008100963300938100963300930810096330093

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic 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 for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy). The laser utilizes a diode/semiconductor chip (as the active medium); it does not include femtosecond pulsing, or fundus imaging technology.

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
00810096330291Fixed Eye Safety FilterFixed Eye Safety Filter 532 nm2023-04-02
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
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
06974851082079BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851082086BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
06974851088019BVLASERNanjing Bestview Laser S&T Co.,Ltd.GEX2026-07-16
08800020106322TRI-BEAMJeisys Medical Inc.GEX2026-07-16
08800020109446TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109453TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109460TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109477TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109484TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109491TRI-BEAM HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109507TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109514TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109521TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109538TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109545TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109552TRI-BEAM PRO HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109651Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109668Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109675Edge HandpieceJeisys Medical Inc.GEX2026-07-16
08800020109682Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109699Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109705Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109712Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109729Edge Guide TipJeisys Medical Inc.GEX2026-07-16
08800020109989FootswitchJeisys Medical Inc.GEX2026-07-16
08800020109996FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110008FootswitchJeisys Medical Inc.GEX2026-07-16
08800020110275SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110282SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16
08800020110299SMOOTHCOOL FilterJeisys Medical Inc.GEX2026-07-16