Product areas
FDA product code distribution
Lumenis, Inc.
Country / region:United States (US)
510(k) submissions
15 total
| K number | Device name | Product code | Class | Decision date |
|---|---|---|---|---|
| K211979 | Lumenis Y&R Laser System | GEX | Class 2 | 2022-06-21 |
| K212703 | AcuPulse CO2 Laser System, Delivery Devices and Accessories | GEX | Class 2 | 2021-10-19 |
| K203544 | UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories | GEX | Class 2 | 2020-12-24 |
| K202428 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Class 2 | 2020-10-22 |
| K201663 | AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories | GEX | Class 2 | 2020-07-16 |
| K193500 | Stellar M22 for Intense Pulsed Light (IPL) and Laser System | GEX | Class 2 | 2020-01-16 |
| K180597 | AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO | GEX | Class 2 | 2018-04-03 |
| K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | GEX | Class 2 | 2017-09-18 |
| K170060 | M22 and ResurFx Systems | GEX | Class 2 | 2017-08-09 |
| K170121 | Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories | GEX | Class 2 | 2017-05-22 |
| K162837 | Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System | GEX | Class 2 | 2017-02-28 |
| K151109 | Lumenis Smart532 Laser System | GEX | Class 2 | 2015-10-30 |
| K151947 | LightSheer Desire Light Laser System | GEX | Class 2 | 2015-08-12 |
| K151331 | The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch | GEX | Class 2 | 2015-06-30 |
| K142860 | Lumenis M22 System | GEX | Class 2 | 2015-01-21 |
Company profile
- Canonical name
- Lumenis, Inc.
- Aliases
- Lumenis, Ltd., Lumenis
- Country
- United States(US)
Cited predicates
56- K100415
—
—
Not ingested - K180597
—
—
Not ingested - K201663
—
—
Not ingested - K202428
—
—
Not ingested - K130193
—
—
Not ingested - K203441
The Alma Hybrid Laser System
- K063808
—
—
Not ingested - K963339
—
—
Not ingested - K951812
—
—
Not ingested - K912029
—
—
Not ingested - K151331
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
- K100415
—
—
Not ingested - K030147
—
—
Not ingested - K022060
—
—
Not ingested - K082809
—
—
Not ingested - K100384
—
—
Not ingested - K100415
—
—
Not ingested - K130164
—
—
Not ingested - K180597
—
—
Not ingested - K201663
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K180597
—
—
Not ingested - K160312
—
—
Not ingested - K133895
—
—
Not ingested - K101555
—
—
Not ingested - K100415
—
—
Not ingested - K082809
—
—
Not ingested - K063001
—
—
Not ingested - K172096
—
—
Not ingested - K170060
—
—
Not ingested - K100384
—
—
Not ingested - K100415
—
—
Not ingested - K130164
—
—
Not ingested - K151947
—
—
Not ingested - K133319
—
—
Not ingested - K053628
—
—
Not ingested - K140388
—
—
Not ingested - K011703
—
—
Not ingested - K100228
—
—
Not ingested - K020839
—
—
Not ingested - K130028
—
—
Not ingested - K142860
Lumenis M22 System
- K111213
—
—
Not ingested - K151109
—
—
Not ingested - K060822
—
—
Not ingested - K022327
—
—
Not ingested - K022181
—
—
Not ingested - K053628
—
—
Not ingested - K030147
—
—
Not ingested - K022327
—
—
Not ingested - K071687
—
—
Not ingested - K040081
—
—
Not ingested - K043173
—
—
Not ingested - K060448
—
—
Not ingested - K063074
—
—
Not ingested - K083733
—
—
Not ingested - K130028
—
—
Not ingested
Lumenis, Inc. references 56 predicate/reference devices
Cited as predicate
39- K252599
Diode Laser Therapy Systems (WLA-02)
- K252529
Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)
Not ingested - K250809
Stellar M22
Not ingested - K240816
MeDioStar
- K232236
Echo
Not ingested - K231718
Holmium Medical Laser
Allengers Global Healthcare Private Limited
Not ingested - K220467
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Not ingested - K213669
LIGHTSCALPEL LS-4020
Not ingested - K213484
SmoothCool HR System
Not ingested - K213261
EpilME
Not ingested - K213252
Dornier Thulio
Not ingested - K212703
AcuPulse CO2 Laser System, Delivery Devices and Accessories
Not ingested - K212703
AcuPulse CO2 Laser System, Delivery Devices and Accessories
Not ingested - K212703
AcuPulse CO2 Laser System, Delivery Devices and Accessories
Not ingested - K211362
SCAR 3
El.En Electronic Engineering Spa
Not ingested - K203544
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories
- K203441
The Alma Hybrid Laser System
- K202702
FLARE Single-Use Surgical Laser Fiber
Realton (Suzhou) Medical Technology Co., Ltd.
Not ingested - K202428
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
- K202428
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Not ingested - K201663
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories
Not ingested - K201594
Primelase Excellence
- K193500
Stellar M22 for Intense Pulsed Light (IPL) and Laser System
Not ingested - K193367
elysion-pro
High Technology Products S.L.U
Not ingested - K192856
MT One
Not ingested - K192600
Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60
Not ingested - K192539
Deka Luxea
El.En Electronic Engineering Spa
Not ingested - K192483
MeDioStar
Asclepion Laser Technologies GmbH
Not ingested - K191321
Primelase Excellence
High Technology Products S.L.U
Not ingested - K183647
SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories)
Olympus Surgical Technologies America
Not ingested - K183307
Magma Spark Pro (Magma Spark Plus, Alpha)
- K180993
Beacon Advanced CO2 Laser System
Not ingested - K170738
InMode Diolaze XL
Not ingested - K170179
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
Not ingested - K170060
M22 and ResurFx Systems
- K162837
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System
Not ingested - K162765
Venus Velocity Diode Laser System
Not ingested - K153566
Magma System
Not ingested - K153566
Magma System
Not ingested
39 submissions cite Lumenis, Inc. as a predicate