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
07290109144641 DEN200028 000
07290109145204 DEN200028 000
07290109145198 DEN200028 000

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.