ASSY FOOTSWITCH PACKAGED

GUDID 00813125010119

IRIDEX CORPORATION

General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system General/multiple surgical diode laser system
Primary Device ID00813125010119
NIH Device Record Keye32f388f-fd74-4ca7-9093-0cfb2338d8e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameASSY FOOTSWITCH PACKAGED
Version Model Number60684
Company DUNS612920785
Company NameIRIDEX CORPORATION
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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com
Phone(800)388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125010119 [Primary]

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-03-24

Devices Manufactured by IRIDEX CORPORATION

00813125015381 - Iridex 577 Laser2024-01-26 The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-W
00813125015473 - Iridex 532 Laser2024-01-26 The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for e
00813125015282 - TxCell for IQ577, Iridex Z 30 & CSO980 2022-08-09 TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)
00813125015305 - TxCell for IQ577, H/S 900BM/BQ & CSO99002022-08-09 TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900
00813125015312 - TxCell for IQ532, Iridex Z 30 & CSO98002022-08-09 TxCell Scanning Laser Delivery System for IQ532, Iridex Z30 & CSO9800 (without prism)
00813125015336 - TxCell for IQ532, H/S 900BM/BQ & CSO99002022-08-09 TxCell Scanning Laser Delivery System for IQ532, H/S 900BM/BQ & CSO9900
00813125015459 - IQ532XP Laser Console2022-02-24
00813125016487 - OcuLight GL Laser Console2022-02-24

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