FDA.reportPublic FDA data

OptiLight IPL MODALITY FILTERS KIT

Primary DI
07290117771891
Brand
OptiLight IPL MODALITY FILTERS KIT
Company
LUMENIS BE LTD
Model
NA
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QIUIntense Pulsed Light Device For Managing Dry Eye

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIUIntense Pulsed Light Device For Managing Dry EyeOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290117771891PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290117771891072901177718917290117771891

GMDN Terms#

Term, Definition table
TermDefinition
Intense pulsed light dry eye therapy unitA portable mains electricity (AC-powered) device intended to treat meibomian blepharitis (dry eye syndrome) by targeting the skin surrounding the meibomian glands (around the eyelid) with intense pulsed light (IPL). It consists of a generator connected to a light-emitting handpiece, and typically includes skin contact gel and light shielding safety glasses. It is intended to be operated by a healthcare professional in a clinical setting.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600763501
Device count
1
Serial number
true
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
07290117771716Digital OptiLight AestheticsLUMENIS BE LTDQIU2023-03-21
07290117771723Digital OptiLight LUMENIS BE LTDQIU2023-03-21
07290117771747Opti-TipLUMENIS BE LTDQIU2023-03-21
07290117771761OPT HandpieceLUMENIS BE LTDQIU2023-03-21
07290117771778OPT Module KitLUMENIS BE LTDQIU2023-03-21
07290117771785OptiLight IPL HandpieceLUMENIS BE LTDQIU2023-03-21
07290117771808OptiLight IPL Module KitLUMENIS BE LTDQIU2023-03-21
07290117771815OptiLightLUMENIS BE LTDQIU2023-03-21
07290117771907IPL Upgrade Kit for OptiLightLUMENIS BE LTDQIU2023-03-21
07290117771914OptiLight IPL HandpieceLUMENIS BE LTDQIU2023-03-21
07290117771921OptiLight FilterLUMENIS BE LTDQIU2023-03-21
07290117771006OptiLight™ AestheticsLUMENIS BE LTDQIU2022-08-10
07290109145303OptiLight IPL Handpiece NFLUMENIS LTD.QIU2021-09-06
07290109144740OptiLight IPL Module Kit LUMENIS LTD.QIU2021-07-25
07290109144894OPT FilterLUMENIS LTD.QIU2021-07-25
07290109144900Rosacea I-III FilterLUMENIS LTD.QIU2021-07-25
07290109144917Rosacea IV-V Filter LUMENIS LTD.QIU2021-07-25
07290109145082OPT Module KitLUMENIS LTD.QIU2021-07-25
07290109145099OPT HandpieceLUMENIS LTD.QIU2021-07-25
07290109145105OptiLight IPL HandpieceLUMENIS LTD.QIU2021-07-25
07290109145259Opti-Tip Treatment KitLUMENIS LTD.QIU2021-07-25
07290109145266Vanilla to OptiLight Upgrade KitLUMENIS LTD.QIU2021-07-25
07290109145273OptiLight IPL Upgrade KitLUMENIS LTD.QIU2021-07-25
07290109145204Stellar Optima System upgrade kitLUMENIS LTD.QIU2021-05-27
17290109145126Stellar Optima Treatment KitLUMENIS LTD.QIU2021-04-13