Stellar Optima Treatment Kit

Primary DI
17290109145126
Brand
Stellar Optima Treatment Kit
Company
LUMENIS LTD.
Model
Stellar Optima Treatment Kit
Published
2021-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
17290109145126PackageGS148In Commercial Distribution
07290109145129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729010914512617290109145126
07290109145129072901091451297290109145129

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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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
07290109142203SurgiTouch™ Scannerkit for AcuPulse and AcuPulse DUOKT-10001002016-08-30
07290109145662SlimLine™SlimLine™ SIS EZ 5500644-020-012022-07-25
07290109141879AcuSpotAcuSpot 712 Micromanipulator AA26300002016-09-13
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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
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
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