Benchmed logo
Benchmed

Lumenis, Inc.

Country / region:United States (US)

510(k) submissions

15
Filtered: GEX

Latest clearance

2022-06-21

Product codes

1
GEX

Cited as predicate

39
View list →

Product areas

FDA product code distribution

GEX15

510(k) submissions

15 total · filtered by GEX

K numberDevice nameProduct codeClassDecision date
K211979Lumenis Y&R Laser SystemGEXClass 22022-06-21
K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesGEXClass 22021-10-19
K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEXClass 22020-12-24
K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEXClass 22020-10-22
K201663AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEXClass 22020-07-16
K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEXClass 22020-01-16
K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEXClass 22018-04-03
K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEXClass 22017-09-18
K170060M22 and ResurFx SystemsGEXClass 22017-08-09
K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEXClass 22017-05-22
K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemGEXClass 22017-02-28
K151109Lumenis Smart532 Laser SystemGEXClass 22015-10-30
K151947LightSheer Desire Light Laser SystemGEXClass 22015-08-12
K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchGEXClass 22015-06-30
K142860Lumenis M22 SystemGEXClass 22015-01-21

Company profile

Canonical name
Lumenis, Inc.
Aliases
Lumenis, Ltd., Lumenis
Country
United States(US)

Cited predicates

56

Lumenis, Inc. references 56 predicate/reference devices

Cited as predicate

39

39 submissions cite Lumenis, Inc. as a predicate