FDA.reportPublic FDA data

Intense pulsed light dry eye therapy unit

Definition
A 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.
GUDID devices
24
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
07290109145129Stellar Optima Treatment KitLUMENIS LTD.Stellar Optima Treatment Kit2021-04-13
07290117771716Digital OptiLight AestheticsLUMENIS BE LTDNA2023-03-21
07290117771723Digital OptiLight LUMENIS BE LTDNA2023-03-21
07290117771747Opti-TipLUMENIS BE LTDNA2023-03-21
07290117771761OPT HandpieceLUMENIS BE LTDNA2023-03-21
07290117771778OPT Module KitLUMENIS BE LTDNA2023-03-21
07290117771785OptiLight IPL HandpieceLUMENIS BE LTDNA2023-03-21
07290117771808OptiLight IPL Module KitLUMENIS BE LTDNA2023-03-21
07290117771815OptiLightLUMENIS BE LTDNA2023-03-21
07290117771891OptiLight IPL MODALITY FILTERS KITLUMENIS BE LTDNA2023-03-21
07290117771907IPL Upgrade Kit for OptiLightLUMENIS BE LTDNA2023-03-21
07290117771914OptiLight IPL HandpieceLUMENIS BE LTDNA2023-03-21
07290117771921OptiLight FilterLUMENIS BE LTDNA2023-03-21
07290117771006OptiLight™ AestheticsLUMENIS BE LTDOptiLight Aesthetics2022-08-10
07290109144740OptiLight IPL Module Kit LUMENIS LTD.OptiLight IPL Module Kit 2021-07-25
07290109144894OPT FilterLUMENIS LTD.OPT Filter2021-07-25
07290109144900Rosacea I-III FilterLUMENIS LTD.Rosacea I-III Filter2021-07-25
07290109144917Rosacea IV-V Filter LUMENIS LTD.Rosacea IV-V Filter 2021-07-25
07290109145082OPT Module KitLUMENIS LTD.OPT Module Kit2021-07-25
07290109145099OPT HandpieceLUMENIS LTD.OPT Handpiece2021-07-25
07290109145259Opti-Tip Treatment KitLUMENIS LTD.Opti-Tip Treatment Kit2021-07-25
07290109145266Vanilla to OptiLight Upgrade KitLUMENIS LTD.Vanilla to OptiLight Upgrade Kit2021-07-25
07290109145204Stellar Optima System upgrade kitLUMENIS LTD.Stellar Optima System upgrade kit2021-05-27
17290109145126Stellar Optima Treatment KitLUMENIS LTD.Stellar Optima Treatment Kit2021-04-13