FDA Registration Active 🇮🇱 Israel

DeepFX Air Disposable Tip

Reg #: 3021349626 · FEI: 3021349626 · Expires 2025
Products
1
Proprietary Names
13
Establishment Types
1
Classifications
1

Registration Details

Registration Name
Lumenis Be Ltd
Registration Number
3021349626
FEI Number
3021349626
Status
Active
Expiry Year
2025
Initial Importer
No
Address
9 Hakidma St, POB # 426, Yokneam Industrial Park
City
Yokneam, Ha Zafon 2069236 Haifa
Country
IL

Regulatory Submissions

510(k) Number
K233301

Owner / Operator

Firm Name
Lumenis Be Ltd.
Operator Number
10082799
Address
9 Hakidma St, POB # 426, Yokneam Industrial Park
City
Yokneam Ha Zafon
State
Haifa
Postal Code
2069236
Country
IL
Correspondent
Shlomit Segman

US Agent

Business Name
Lumenis Be Inc
Contact Name
Michael Robinson
Address
1870 S Milestone Dr
City
Salt Lake City
State
UT
ZIP
84104
Country
US
Phone
801 6562574

Products

Device Name Product Code
Powered Laser Surgical Instrument GEX

Proprietary Names

DeepFX Air Disposable Tip UltraPulse Alpha OR FemX Disposable tips FemTouch Disposable Tips UltraPulse Alpha Office Focused Incisional Handpiece Set TrueSpot Collimated 2 mm Handpiece DeepFX Microscanner FemTouch reusable tips DeepFX Disposable Tip Ultrascan CPG Scanner FemTouch Adaptor kit FemX Adaptor kit

Establishment Types

Manufacture Medical Device