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510(k) DEN200028

Lumenis Stellar M22 by Lumenis, Ltd. — Product Code QIU

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
February 23, 2021
Date Received
April 20, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intense Pulsed Light Device For Managing Dry Eye
Device Class
Class II
Regulation Number
886.5201
Review Panel
OP
Submission Type

An intense pulsed light device for managing dry eye is a prescription device intended for use in the application of intense pulsed light therapy to the skin. The device is used in patients with dry eye disease due to meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

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