LIO 577nm w/HEINE OMEGA 500

GUDID 00813125014650

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 ID00813125014650
NIH Device Record Keyad43a454-bfe6-4a71-bd37-c8b3014c11a8
Commercial Distribution StatusIn Commercial Distribution
Brand NameLIO 577nm w/HEINE OMEGA 500
Version Model Number65900-H500
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 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

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
GS100813125014650 [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 Date2016-09-24

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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