Elite iQ M122B1

GUDID 08057017760450

The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the Nd:YAG (1064-nm) and Alexandrite (755-nm) wavelengths. Through various spot sizes, fluences and repetition rates, the system offers hair removal treatment and aesthetic treatments across all skin types. An Alexandrite standalone workstation is also available for purchase. The Elite iQ delivers the laser energy through a lens-coupled optical fiber with a wide range of interchangeable, quick-release laser handpieces with electronic spot recognition. The Elite iQ also includes the Skintel® Melanin Reader for objective measurement of the melanin content of skin. The locking casters allow this stand-alone laser system to be secured in place, as well as to be conveniently moved or transported. When not in use, handpiece components and other system components can be stowed in the storage area located in the side drawer. All system connections, such as the foot switch and remote interlock connections, are located on the rear of the laser. This includes all applicable device labels. User-selectable controls and functions are located on the front of the laser. Elite iQ software features include a Windows® operating system, LCD touch screen and a state-of-the-art graphic user interface.

EL.EN. SPA

Multi-modality skin surface treatment system
Primary Device ID08057017760450
NIH Device Record Key141c85a9-d935-42bc-adf4-ac63992e9c91
Commercial Distribution StatusIn Commercial Distribution
Brand NameElite iQ
Version Model NumberM122B1
Catalog NumberM122B1
Company DUNS436887608
Company NameEL.EN. SPA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS108057017760450 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-23
Device Publish Date2020-03-13

On-Brand Devices [Elite iQ]

08057017760467The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the N
08057017760450The Elite iQ™ workstation is a dual wavelength system that delivers laser energy in both the N

Trademark Results [Elite iQ]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ELITE IQ
ELITE IQ
88665680 not registered Live/Pending
Cynosure, LLC
2019-10-23

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