DEVICE: ADVATx (05700002052209)

Download: XML | JSON

Device Identifier (DI) Information

ADVATx
1.0
684
Advalight ApS
05700002052209
GS1
1
The laser system is for dermatological indications for use. The laser light is delivered to the patient through an applicator either a scanning hand piece or a single spot hand piece (optional). The ADVATx Laser System consists of a laser cabinet which houses the laser module, the user interface which allows the user to control the system and the laser delivery system. ADVATx does only come in one model. The laser does not use any consumables (besides standard power/electricity), and no accessories are offered. The ADVATx laser system is a Nd:YAG laser delivering 589nm Q-switched pulsed light and 1319nm continuous wave light. This laser has been developed specifically for dermatological (skin) treatments performed by healthcare professionals e.g. doctors.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Dermatological frequency-doubled solid-state laser system A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended to cut, excise, ablate, and vaporize soft tissues in dermatological applications such as vascular/skin lesion, tattoo, and hair removal; it includes frequency doubling technology whereby the operator can select one of two energy wavelengths (1064 or 532 nm). It includes a light source, delivery/positioning device(s), and controls/foot-switch, and may be operated in continuous-wave or pulsed modes.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered Laser Surgical Instrument
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Handling Environment Atmospheric Pressure: between 80 and 150 KiloPascal
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between 0 and 50 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 18, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05700002052216 1 05700002052209 In Commercial Distribution colli
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+4546965412
tma@advalight.com
CLOSE