Diode laser FOX 1064 nm. LS03200

GUDID 04260155593017

FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um

A.R.C. Laser GmbH

General/multiple surgical diode laser system
Primary Device ID04260155593017
NIH Device Record Keyc7ad3669-e529-47b8-bc10-1af2a57f17a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiode laser FOX 1064 nm.
Version Model NumberLS03200
Catalog NumberLS03200
Company DUNS314885641
Company NameA.R.C. Laser GmbH
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

Device Identifiers

Device Issuing AgencyDevice ID
GS104260155593017 [Primary]
GS104260155593024 [Package]
Package: [1 Units]
In Commercial Distribution

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 Date2019-11-27
Device Publish Date2019-11-19

Devices Manufactured by A.R.C. Laser GmbH

04260155593017 - Diode laser FOX 1064 nm.2019-11-27FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um
04260155593017 - Diode laser FOX 1064 nm.2019-11-27 FOX 1064 nm Diode laser, aiming beam 532 nm, coupling 300 um
04260155590078 - Diode laser FOX 980 nm.2019-05-16 FOX 980nm. Diode Laser Aiming Beam 532nm. Coupling 300um
04260155591921 - Laser Surgery Fibers and Probes2018-07-06 Otology probe curved tip 20° universal centering
04260155591914 - Laser Surgery Fibers and Probes2018-07-06 Otology probe long universal centering
04260155591907 - Laser Surgery Fibers and Probes2018-07-06 Bare fiber 400 μm universal centering 1470 nm
04260155591891 - Laser Surgery Fibers and Probes2018-07-06 Bare fiber 600 μm/400 µm
04260155591884 - Laser Surgery Fibers and Probes2018-07-06 Bare fiber 400μm/300µm
04260155591877 - Laser Surgery Fibers and Probes2018-07-06 Endo probe 25 gauge

© 2019 FDA.report
This site is not affiliated with or endorsed by the FDA.