SLA (532 nm)

GUDID 00813125017019

for Zeiss 30 CSO or equivalent

IRIDEX CORPORATION

General/multiple surgical diode laser system
Primary Device ID00813125017019
NIH Device Record Key0bd41a6e-21a0-425f-ba2a-386ee81a2dfa
Commercial Distribution StatusIn Commercial Distribution
Brand NameSLA (532 nm)
Version Model Number65505
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
Phone(800) 388-4747
Emailtechsupport@iridex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100813125017019 [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 Date2024-05-14
Device Publish Date2024-05-06

Devices Manufactured by IRIDEX CORPORATION

00813125010249 - Eye Safety Filter, Fixed (532 nm) 2024-10-30 For use on the Moeller-Wedel Dovetails OD3 @ 532 nm
00813125010256 - Eye Safety Filter, Fixed (532 nm)2024-10-30 For use on the Leica M841 Dovetails OD3 @ 532 nm
00813125010263 - Eye Safety Filter, Two-Position (532 nm)2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 532 nm
00813125010270 - Eye Safety Filter, Two-Position (532 nm)2024-10-30 For use on the Zeiss Dovetails OD3 @ 532 nm
00813125014490 - Eye Safety Filter, Two-Position (577 nm)2024-10-30 For use on the Leica or Wild Dovetails OD3 @ 577 nm
00813125014506 - Eye Safety Filter, Two-Position (577 nm)2024-10-30 For use on the Zeiss Dovetails OD3 @ 577 nm
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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