Lumenis, Ltd. - FDA 510(k) Cleared Devices

Cleared Oct 19, 2021

AcuPulse CO2 Laser System, Delivery Devices and Accessories

K212703 · GEX

General & Plastic Surgery · 54d

Cleared Dec 24, 2020

UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and...

K203544 · GEX

General & Plastic Surgery · 20d

Cleared Oct 22, 2020

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

K202428 · GEX

General & Plastic Surgery · 58d

Cleared Jul 16, 2020

AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories

K201663 · GEX

General & Plastic Surgery · 27d

Cleared Jan 16, 2020

Stellar M22 for Intense Pulsed Light (IPL) and Laser System

K193500 · GEX

General & Plastic Surgery · 30d

Cleared Apr 03, 2018

AcuPulse (previously called AcuPulse 30/40 ST)

K180597 · GEX

General & Plastic Surgery · 28d

Cleared Sep 18, 2017

LightSheer Desire

K170179 · GEX

General & Plastic Surgery · 242d

Cleared Aug 09, 2017

M22 and ResurFx Systems

K170060 · GEX

General & Plastic Surgery · 215d

Cleared May 22, 2017

Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories

K170121 · GEX

General & Plastic Surgery · 129d

Cleared Feb 28, 2017

Smart Laser Indirect Ophthalmoscope (LIO)

K162837 · GEX

General & Plastic Surgery · 140d

Cleared Aug 12, 2015

LightSheer Desire Light Laser System

K151947 · GEX

General & Plastic Surgery · 28d

Cleared Jun 30, 2015

The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the...

K151331 · GEX

General & Plastic Surgery · 42d