Lightwalker DT

GUDID 03830054230095

"The Fotona LightWalker laser system range incorporates treatment lasers that operate in the invisible near-infrared (Nd:YAG 1064 nm) and mid-infrared (Er:YAG 2940 nm) ranges of the electromagnetic spectrum, along with an aiming beam laser that operates in the visible range. The incorporated lasers and their handpieces were developed for therapeutic use in dentistry for soft- and hard-tissue treatments, and for use in aesthetic and dermatological procedures. The Er:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. The Nd:YAG laser and its accessories are intended to be used for medical applications in the fields of aesthetics & dermatology, dentistry, and surgery. "

FOTONA d.o.o.

General/multiple surgical solid-state laser system
Primary Device ID03830054230095
NIH Device Record Keyd975ab4a-2cee-4638-ad6b-d2bb5efba049
Commercial Distribution StatusIn Commercial Distribution
Brand NameLightwalker DT
Version Model NumberM021-5AF/2
Company DUNS644720625
Company NameFOTONA d.o.o.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 700 KiloPascal and 1060 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS103830054230095 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-06
Device Publish Date2016-09-19

Devices Manufactured by FOTONA d.o.o.

03830054230361 - AvalancheLase2023-03-15 The device and its accessories are intended to be used in the fields of aesthetics and dermatology.
03830054230378 - AvalancheLase2023-03-15 The device and its accessories are intended to be used in the fields of aesthetics and dermatology.
03830054230507 - TimeWalker AT2021-12-09 The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urolo
03830054230514 - TimeWalker ST-E2021-12-09 The device and its accessories are intended to be used in the fields of dentistry, aesthetics, dermatology, gynecology and urolo
03830054230064 - Fotona QX Max2021-08-24 The Fotona QX laser system family incorporates a treatment laser that operates in the invisible mid-infrared and visible range o
03830054230330 - StarWalker2021-08-24 The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmen
03830054230354 - StarWalker2021-08-24 The StarWalker Fotona QX MAX (QX and MaQX) laser system and its accessories are intended for tattoo removal, treatment of pigmen
03830054230484 - StarWalker2021-02-05 The Fotona StarWalker PQX laser system and its accessories are intended for tattoo removal, treatment of pigmented lesions and a

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.