Lumenis Stellar M22

Intense Pulsed Light Device For Managing Dry Eye

Lumenis Ltd.

The following data is part of a De Novo classification by Lumenis Ltd. with the FDA for Lumenis Stellar M22.

Pre-market Notification Details

DeNovo IDDEN200028
Device Name:Lumenis Stellar M22
ClassificationIntense Pulsed Light Device For Managing Dry Eye
Applicant Lumenis Ltd. 6 Hakidma Street Po Box 240 Yokneam,  IL 2069204
ContactShlomit Segman
Product CodeQIU  
CFR Regulation Number886.5201 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationDevice Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin
Review Advisory BoardOphthalmic
Classification AdvisoryOphthalmic
TypeDirect
Date Received2020-04-20
Decision Date2021-02-23
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17290109145126 DEN200028 000
07290109144740 DEN200028 000
07290109144894 DEN200028 000
07290109144900 DEN200028 000
07290109144917 DEN200028 000
07290109145082 DEN200028 000
07290109145099 DEN200028 000
07290109145105 DEN200028 000
07290109145259 DEN200028 000
07290109145266 DEN200028 000
07290109145273 DEN200028 000
07290109145280 DEN200028 000
07290109145198 DEN200028 000
07290109145204 DEN200028 000
07290109144641 DEN200028 000
07290109145303 DEN200028 000

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