Opti-Tip Treatment Kit

Primary DI
07290109145259
Brand
Opti-Tip Treatment Kit
Company
LUMENIS LTD.
Model
Opti-Tip Treatment Kit
Published
2021-07-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN200028000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN200028000Lumenis Stellar M22Lumenis, Ltd.2021-02-23QIU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290109145256PackageGS148In Commercial Distribution
07290109145259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010914525617290109145256
07290109145259072901091452597290109145259

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
600166524
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

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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
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07290109145662SlimLine™SlimLine™ SIS EZ 5500644-020-012022-07-25
07290109141879AcuSpotAcuSpot 712 Micromanipulator AA26300002016-09-13
07290109141916AcuSpotAcuSpot 712 L Micromanipulator AA30420002016-09-13

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
07290117771891OptiLight IPL MODALITY FILTERS KITLUMENIS 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
07290109145266Vanilla to OptiLight Upgrade KitLUMENIS LTD.QIU2021-07-25
07290109145273OptiLight IPL Upgrade KitLUMENIS LTD.QIU2021-07-25
07290109145280OptiLight™LUMENIS LTD.QIU2021-07-25
07290109145204Stellar Optima System upgrade kitLUMENIS LTD.QIU2021-05-27
07290109145129Stellar Optima Treatment KitLUMENIS LTD.QIU2021-04-13
07290109144641Stellar Optima™LUMENIS LTD.QIU2021-04-13
17290109145126Stellar Optima Treatment KitLUMENIS LTD.QIU2021-04-13