FDA Registration
Active
🇺🇸 United States
M22 IPL handpiece
Reg #: 1720381
·
FEI: 1720381
·
Expires 2025
Products
1
Proprietary Names
46
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- LUMENIS, INC.
- Registration Number
- 1720381
- FEI Number
- 1720381
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1870 S Milestone Dr
- City
- SALT LAKE CITY
- State
- UT
- ZIP
- 84104
- Country
- US
Owner / Operator
- Firm Name
- Lumenis Be LTD
- Operator Number
- 9017014
- Address
- 9 Hakidma St., POB 426, Yokneam Industrial Park
- City
- Yokneam
- State
- IL-NOTA
- Postal Code
- 2069236
- Country
- IL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-07-15 |
Proprietary Names
M22 IPL handpiece
FiberLase ENDURE CO2 Fiber
FiberLase Sterilization Tray
MicroLase Otology Set
Duotome Sidelite Fiber
Acupulse Incisional Handpiece 125 mm
OtoLase
Nasal and Laryngeal Probes
VersaPulse PowerSuite 60W
Lumenis Pulse 120H
AcuPulse
LightSheer Desire Light
M22 IPL and Nd:YAG module
VersaPulse PowerSuite 100W
FemTouch
LightSheer ET Handpiece
LightSheer XC Handpiece
SurgiTouch Scanning Handpiece Set
AcuSpot 712 Micromanipulators
Lumenis Pulse 30H
LightSheer HS Handpiece
M22 Q-Switched module
FiberLase Endoscope Protection Sheath
Micro-H Otology Kit
Fiberlase Handpieces
LightSheer DESIRE
Xpeeda D/F/L
IPL Filters
FiberLase Endoscope Protection Sheath
Acne Filter
FiberLase CO2 Fiber
VersaPulse PowerSuite 80W/100W
Micro-G Otology Kit
OtoLase
High-Speed Disposables Kit
M22 ResurFX module
AcuPulse 40WG
Lumenis Pulse 100H
Vascular Filter
IPL LightGuides
FiberLase Handpieces
LightSheer Desire
AcuPulse DUO
MicroLase Fiber
Sterilization Tray
Lumenis Pulse 50H
Establishment Types
Manufacture Device in the United States for Export Only