Iridex Corp

FDA Filings

This page includes the latest FDA filings for Iridex Corp. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

USANASDAQIRIXDUNS 612920785
FDA Registration(s)
Registration Number2939653
FEI Number2939653
NameIRIDEX CORP.
Owner & OperatorIRIDEX Corporation
Contact Address1212 Terra Bella Avenue --
Mountain View CA 94043 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1212 Terra Bella Ave
MOUNTAIN VIEW, CA 94043 US
Establishment Type
  • Repack or Relabel Medical Device
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
Iridex Corporation
Iridex 810 Laser2020-10-21
IRIDEX CORPORATION
20G Fluted EndoProbe® Single 2019-11-06
IRIDEX CORPORATION
20G Fluted EndoProbe® Box of 6 2019-11-06
IRIDEX CORPORATION
Safety Filter 532 nm Topcon OMS 300/320 2019-05-09
IRIDEX CORPORATION
MicroPulse P3 Device Single 2019-03-18
IRIDEX CORPORATION
MicroPulse P3 Device Box of 6 2019-03-18
IRIDEX CORP. [IRIDEX Corporation]
Slit lamp Biomicroscope2019-03-08
IRIDEX CORP. [IRIDEX Corporation]
Instrument table2019-03-08
IRIDEX CORP. [IRIDEX Corporation]
TruFocus LIO Premiere2018-09-07
Iridex Corporation
Iridex TruFocus LIO Premiere2018-09-05
IRIDEX CORPORATION
SLx Laser Console 2018-07-06
IRIDEX CORPORATION
SL Laser Console 2018-07-06
IRIDEX CORPORATION
SL Laser Console 220V 2018-07-06
IRIDEX CORPORATION
OcuLight SLx Tri-Mode Console 115V 2018-07-06
IRIDEX CORPORATION
TruFocus LIO Premiere 873002018-07-06
IRIDEX CORPORATION
TruFocus LIO Premiere 873022018-07-06
IRIDEX CORPORATION
TruFocus LIO Premiere 873012018-07-06
IRIDEX CORPORATION
TruFocus LIO Premiere 873032018-07-06
IRIDEX CORPORATION
TruFocus LIO Premiere 873042018-07-06
IRIDEX CORPORATION
20G Angled LRE EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
20G Angled LRE EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
OtoProbe™ Long Angled Single 2018-03-29
IRIDEX CORPORATION
23G BriteLight™ EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
23-27G Angled 45° EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
20G Straight EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
G-Probe™ Single 2018-03-29
IRIDEX CORPORATION
G-Probe™ Box of 6 2018-03-29
IRIDEX CORPORATION
23G BriteLight™ EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23-27G Angled 45° EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
25G Straight EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
20G Straight EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23G Finger Adjustable & Intuitive XR, EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
20G Angled 45° EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
20G Angled 45° EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25G Finger Adjustable & Intuitive XR, EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
25G Finger Adjustable & Intuitive XR, EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
OtoProbe™ Short Angled Box of 6 2018-03-29
IRIDEX CORPORATION
OtoProbe™ Short Angled Single 2018-03-29
IRIDEX CORPORATION
OtoProbe™ Long Angled Box of 6 2018-03-29
IRIDEX CORPORATION
23G Finger Adjustable & Intuitive EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23G Finger Adjustable & Intuitive EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
23G Thumb Adjustable & Intuitive EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23G Thumb Adjustable & Intuitive EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25G Straight Endoprobe® Single 2018-03-29
IRIDEX CORPORATION
25G Thumb Adjustable & Intuitive EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
25G Thumb Adjustable & Intuitive EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25G BriteLight™ EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
25G BriteLight™ EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
23-27G BriteLight™ Angled 45° EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23-27G BriteLight™ Angled 45° EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
23G Straight EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
23G Straight EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25-30G Angled 45° EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
25-30G Angled 45° EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25-27G BriteLight™ Angled 20° EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
G-Probe™ Illuminate Box of 6 2018-03-29
IRIDEX CORPORATION
G-Probe™ Illuminate Single 2018-03-29
IRIDEX CORPORATION
Assy Final HS SLA IQ532 Standard Mount 2018-03-29
IRIDEX CORPORATION
LIO+810 w/Heine Headset IR LIO w/ Omega 500 Head set 2018-03-29
IRIDEX CORPORATION
RFID LIO+ 532nm w/Heine Omega Headband 2018-03-29
IRIDEX CORPORATION
ML LIO+ w/Heine Headset Dual wavelength OMEGA 500 2018-03-29
IRIDEX CORPORATION
Scanner, TxCell Z120/577 2018-03-29
IRIDEX CORPORATION
Scanner, TxCell Z30/532 2018-03-29
IRIDEX CORPORATION
TX Laser Console 2018-03-29
IRIDEX CORPORATION
GLX NEO, Laser Console 2018-03-29
IRIDEX CORPORATION
25-27G BriteLight™ Angled 20° EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
IQ810 Laser Console 2018-03-29
IRIDEX CORPORATION
Cyclo G6 Laser Console 2018-03-29
IRIDEX CORPORATION
G-Probe™ Illuminate Single 2018-03-29
IRIDEX CORPORATION
G-Probe™ Illuminate Box of 6 2018-03-29
IRIDEX CORPORATION
MicroPulse® P3 Device Single 2018-03-29
IRIDEX CORPORATION
MicroPulse® P3 Device Box of 6 2018-03-29
IRIDEX CORPORATION
G-Probe™ RFID Box of 6 2018-03-29
IRIDEX CORPORATION
G-Probe™ RFID Single 2018-03-29
IRIDEX CORPORATION
Zeiss Dovetail 577nm ESF 2018-03-29
IRIDEX CORPORATION
577nm Fixed Eye Safety Filter Leica/Wild 2018-03-29
IRIDEX CORPORATION
Assy, Top Zeiss 130 SLA 2018-03-29
IRIDEX CORPORATION
SLA IQ532 Zeiss 30 2018-03-29
IRIDEX CORPORATION
LIO 577nm w/HEINE OMEGA 500 2018-03-29
IRIDEX CORPORATION
SLA IQ577 HS BM/BQ 2018-03-29
IRIDEX CORPORATION
Assy Illumination Adapter B & L Stellaris 2018-03-29
IRIDEX CORPORATION
FlexFiber™ 600, Box of 6 2018-03-29
IRIDEX CORPORATION
FlexFiber™ 600, Single 2018-03-29
IRIDEX CORPORATION
Assy Illumination Adapter Bright Star 2018-03-29
IRIDEX CORPORATION
25G Finger Adjustable & Intuitive, EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
25G Finger Adjustable & Intuitive, EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
20G Finger Adjustable & Intuitive EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
20G Finger Adjustable & Intuitive EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
Illuminating Bayonet EndoProbe® Handpiece 2018-03-29
IRIDEX CORPORATION
23G Straight RFID EndoProbe® Single 2018-03-29
IRIDEX CORPORATION
23G Straight RFID EndoProbe® Box of 6 2018-03-29
IRIDEX CORPORATION
ASSEMBLY, TOP 5MM LS SLA, HS 900BQ 2018-03-29
IRIDEX CORPORATION
ASSEMBLY, TOP 5mm LS SLA, HS 2018-03-29
IRIDEX CORPORATION
SLA 532nm 50 um Haag Streit 900 BM 2018-03-29
IRIDEX CORPORATION
SLA 532nm 50 um Haag Streit 900 BM w/MM 2018-03-29
IRIDEX CORPORATION
SLA 532nm EasyFit Zeiss 30 2018-03-29
IRIDEX CORPORATION
Assy Illumination Adapter PHOTON 2018-03-29
IRIDEX CORPORATION
Safety Filter 532nm Leica/Wild Dovetail M650/M690 2018-03-29
IRIDEX CORPORATION
Safety Filter 532nm Zeiss Dovetail 2018-03-29
IRIDEX CORPORATION
Safety Filter 810nm Leica/Wild Dovetail 2018-03-29
IRIDEX CORPORATION
Safety Filter 810nm Zeiss Dovetail 2018-03-29
IRIDEX CORPORATION
ASSY FOOTSWITCH PACKAGED 2018-03-29
IRIDEX CORPORATION
Footswitch Half Assembly 2018-03-29
IRIDEX CORPORATION
Wireless Footswitch Power Adjust 2018-03-29
IRIDEX CORP. [IRIDEX Corporation]
TruFocus LIO Premiere2018-02-26
Iridex Corporation
Iridex TruFocus LIO Premiere2017-05-03
IRIDEX CORP. [IRIDEX Corporation]
G-Probe Illuminate2017-03-16
IRIDEX CORPORATION
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate2016-09-29
IRIDEX CORPORATION
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)2015-01-02
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Surgical Scraper , 23 GA & 25 GA2013-09-12
IRIDEX CORP.
TXCELL SCANNING LASER DELIVERY SYSTEM2012-11-28
IRIDEX CORP. [IRIDEX Corporation]
Light Pipe2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 25 Gauge Tip Length: 2.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 25 Gauge Tip Length: 1 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 25 Gauge Tip Length: 0.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 25 Gauge Brush Tip Length: 2.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 23 Gauge Tip Length: 2.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 23 Gauge Tip Length: 1 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 23 Gauge Brush Tip Length: 2.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 23 Gauge Brush Tip Length: 0.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 20 Gauge Tip Length: 1 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 20 Gauge Tip Length: 0.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
GreenTipTM Soft Tip Cannula 20 Gauge Brush Tip Length: 2.5 MM Box (Qty 12)2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
Green Tip2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
10 Pack Box, 25 Ga Cannula, GreenTip, Soft Tip 0.5 Mm2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
10 Pack Box, 25 Ga Cannula, Green Tip, Soft Tip 1.0 Mm2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
10 Pack Box, 23 Ga Cannula, GreenTip, Soft Tip 0.5 mm2010-12-27
IRIDEX CORP. [IRIDEX Corporation]
10 Pack Box, 23 Ga Cannula, Green Tip, Soft Tip 1.0 Mm2010-12-27
IRIDEX CORP.
FAMILI OF IRIDEX IQ LASER SYSTEMS2008-08-07
IRIDEX CORP. [IRIDEX Corporation]
OcuLight SL/SLx2008-03-03
IRIDEX CORP. [IRIDEX Corporation]
OcuLight SL/SLx2008-03-03
IRIDEX CORP.
IRIDEX WIRELESS FOOTSWITCH2006-11-14
IRIDEX CORP.
IRIDEX OCULIGHT TX2006-11-08
IRIDEX CORP.
IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-12006-05-31
IRIDEX CORP.
IRIS MEDICAL IQ 810 PHOTOCOAGULATOR2004-09-20
IRIDEX CORPORATION
VARILITE LASER SYSTEM2004-09-10
IRIDEX CORP.
IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS2003-08-27
IRIDEX CORP.
FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES2002-10-08
IRIDEX CORP.
APEX 800 LASER SYSTEM, MODEL APEX 8002002-05-20
IRIDEX CORP.
OCULIGHT SL/SLX2002-05-03
IRIDEX CORP.
IRIDERM, MODEL APEX 8001999-12-09
IRIDEX CORP.
OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE1998-09-08

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