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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name intense pulsed light device for managing dry eye
De Novo Number DEN200028
Device Name Lumenis Stellar M22
Requester
lumenis, ltd.
6 hakidma st. p.o. box 240
yokneam,  IL 2069204
Contact shlomit segman
Regulation Number886.5201
Classification Product Code
QIU  
Date Received04/20/2020
Decision Date 02/23/2021
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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