Wireless Footswitch Power Adjust

GUDID 00813125010096

IRIDEX CORPORATION

General/multiple surgical diode laser system
Primary Device ID00813125010096
NIH Device Record Keya63543e9-02cf-4e68-8fe4-46024f069e24
Commercial Distribution StatusIn Commercial Distribution
Brand NameWireless Footswitch Power Adjust
Version Model Number31808
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
GS100813125010096 [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

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00813125014513 - Eye Safety Filter, Two-Position (532 nm)2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125014520 - Eye Safety Filter, Two-Position (532 nm)2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm

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