TxCell for IQ577, H/S 900BM/BQ & CSO9900

GUDID 00813125015305

TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900

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
Primary Device ID00813125015305
NIH Device Record Key5d2f4627-5e8f-4a02-aabc-384e5a5d2cd6
Commercial Distribution StatusIn Commercial Distribution
Brand NameTxCell for IQ577, H/S 900BM/BQ & CSO9900
Version Model Number70295
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125015305 [Primary]

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 Date2022-08-09
Device Publish Date2022-08-01

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 & CSO99002022-08-09TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900
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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