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510(k) DEN200028

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

DEN200028 is an FDA 510(k) premarket notification submitted by Lumenis, Ltd. for the device "Lumenis Stellar M22". The FDA issued a decision of De Novo Granted on February 23, 2021. The device falls under product code QIU (Intense Pulsed Light Device For Managing Dry Eye), a Class II device regulated under 21 CFR 886.5201. Lumenis, Ltd. has at least 10 other 510(k) clearances on record.

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.

Other clearances by Lumenis, Ltd.

  • K211979 — Lumenis Y&R Laser System (June 21, 2022)
  • K212703 — AcuPulse CO2 Laser System, Delivery Devices and Accessories (October 19, 2021)
  • K203544 — UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accesso (December 24, 2020)
  • K202428 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (October 22, 2020)
  • K201663 — AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (July 16, 2020)
  • K193500 — Stellar M22 for Intense Pulsed Light (IPL) and Laser System (January 16, 2020)
  • K180597 — AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (April 3, 2018)
  • K170179 — LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (September 18, 2017)
  • K170060 — M22 and ResurFx Systems (August 9, 2017)
  • K170121 — Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (May 22, 2017)

FDA data resources