Iridex Corporation

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2939653	2939653	Iridex Corporation	1	N	2026-01-01	1212 Terra Bella Avenue MOUNTAIN VIEW CA US 94043
3048506982	3048506982	Iridex Corporation	1	N	2026-01-01	5215 Hellyer Avenue Suite 150 San Jose CA US 95138

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00813125010249	Eye Safety Filter, Fixed (532 nm) - For use on the Moeller-Wedel DovetailsOD3 @ 532 nm	(800) 388-4747	techsupport@iridex.com
00813125010256	Eye Safety Filter, Fixed (532 nm) - For use on the Leica M841 DovetailsOD3 @ 532 nm	(800) 388-4747	techsupport@iridex.com

iridex.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
352899	1060817934	K992836	SL990, SL980, SL950	HJO	1999-11-09
43232	1060817934	K992836	SL990, SL980, SL950	HJO	1999-11-09
352899	1869272924	K992298	IRIDERM, MODEL APEX 800	GEX	1999-12-09
43232	1869272924	K992298	IRIDERM, MODEL APEX 800	GEX	1999-12-09
352899	1147506939	K974561	MOISTAIR FLUID AIR TUBING SET	KYG	1998-02-19
43232	1147506939	K974561	MOISTAIR FLUID AIR TUBING SET	KYG	1998-02-19
43232	1257355369	K971853	ENDOVIEW SPPHIRE LENS SET	HJK	1997-08-06
352899	1257355369	K971853	ENDOVIEW SPPHIRE LENS SET	HJK	1997-08-06
43232	1759631260	K970875	ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)	MPA	1997-05-20
352899	1759631260	K970875	ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.)	MPA	1997-05-20
43232	1618401029	K970873	ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)	HMX	1997-05-20
352899	1618401029	K970873	ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)	HMX	1997-05-20
43232	2020810819	K230228	Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)	HQF	2023-02-23
352899	2020810819	K230228	Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)	HQF	2023-02-23
43232	1385757592	K223132	Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)	HQF	2022-11-09
352899	1385757592	K223132	Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)	HQF	2022-11-09
43232	1099537372	K202760	Iridex 810 Laser	HQF	2020-10-21
352899	1099537372	K202760	Iridex 810 Laser	HQF	2020-10-21
43232	1434313153	K181662	Iridex TruFocus LIO Premiere	GEX	2018-09-05
352899	1434313153	K181662	Iridex TruFocus LIO Premiere	GEX	2018-09-05
43232	1847379015	K180402	PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar	HQF	2018-05-25
352899	1847379015	K180402	PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar	HQF	2018-05-25
43232	1727649601	K171488	PSLT for PASCAL Streamline	HQF	2017-11-27
352899	1727649601	K171488	PSLT for PASCAL Streamline	HQF	2017-11-27
43232	1954731106	K170718	Iridex TruFocus LIO Premiere	GEX	2017-05-03
352899	1954731106	K170718	Iridex TruFocus LIO Premiere	GEX	2017-05-03
43232	1829588052	K170409	PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System	GEX	2017-09-12
352899	1829588052	K170409	PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System	GEX	2017-09-12
43232	1188365535	K162416	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate	GEX	2016-09-29
352899	1188365535	K162416	IRIDEX Cyclo G6 Laser System, G-Probe Illuminate	GEX	2016-09-29
43232	1101899992	K143154	IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)	GEX	2015-01-02
352899	1101899992	K143154	IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)	GEX	2015-01-02
43232	1903412029	K123542	PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER	HQF	2013-05-15
352899	1903412029	K123542	PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER	HQF	2013-05-15
43232	1031634028	K123056	PASCAL LASER INDIRECT OPHTHALMOSCOPE	HQF	2012-11-13
352899	1031634028	K123056	PASCAL LASER INDIRECT OPHTHALMOSCOPE	HQF	2012-11-13
43232	2017374054	K121475	TXCELL SCANNING LASER DELIVERY SYSTEM	GEX	2012-11-28
352899	2017374054	K121475	TXCELL SCANNING LASER DELIVERY SYSTEM	GEX	2012-11-28
352899	1275963967	K111108	PASCAL STREAMLINE 577 (WITH ACCESSORIES)	HQF	2011-08-11
43232	1275963967	K111108	PASCAL STREAMLINE 577 (WITH ACCESSORIES)	HQF	2011-08-11
43232	1601191365	K100019	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2010-05-04
352899	1601191365	K100019	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2010-05-04
43232	1366591561	K092621	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2009-09-25
352899	1366591561	K092621	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2009-09-25
43232	1485342515	K091666	PASCAL PHOTOCOAGULATOR, PASCAL-US	GEX	2009-07-15
352899	1485342515	K091666	PASCAL PHOTOCOAGULATOR, PASCAL-US	GEX	2009-07-15
43232	1648737664	K081744	PASCAL SYNTHESIS DELIVERY SYSTEM	GEX	2008-09-09
352899	1648737664	K081744	PASCAL SYNTHESIS DELIVERY SYSTEM	GEX	2008-09-09
43232	1847147784	K071687	FAMILI OF IRIDEX IQ LASER SYSTEMS	GEX	2008-08-07
352899	1847147784	K071687	FAMILI OF IRIDEX IQ LASER SYSTEMS	GEX	2008-08-07
43232	1381430993	K062369	IRIDEX OCULIGHT TX	GEX	2006-11-08
352899	1381430993	K062369	IRIDEX OCULIGHT TX	GEX	2006-11-08
43232	1064481340	K062336	OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE	GEX	2006-10-19
352899	1064481340	K062336	OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE	GEX	2006-10-19
43232	1031189236	K062074	IRIDEX WIRELESS FOOTSWITCH	HQF	2006-11-14
352899	1031189236	K062074	IRIDEX WIRELESS FOOTSWITCH	HQF	2006-11-14
43232	1109577856	K060905	IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1	GEX	2006-05-31
352899	1109577856	K060905	IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1	GEX	2006-05-31
43232	1549937890	K050562	OCULIGHT GL/GLX	GEX	2005-04-14
352899	1549937890	K050562	OCULIGHT GL/GLX	GEX	2005-04-14
43232	1598092951	K043486	PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01	GEX	2005-03-03
352899	1598092951	K043486	PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01	GEX	2005-03-03
43232	1133736109	K040209	IRIS MEDICAL IQ 810 PHOTOCOAGULATOR	HQF	2004-09-20
352899	1133736109	K040209	IRIS MEDICAL IQ 810 PHOTOCOAGULATOR	HQF	2004-09-20
43232	1799551584	K031665	IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS	HQF	2003-08-27
352899	1799551584	K031665	IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS	HQF	2003-08-27
43232	1317038429	K022228	FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES	GEX	2002-10-08
352899	1317038429	K022228	FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES	GEX	2002-10-08
43232	1490085928	K020849	APEX 800 LASER SYSTEM, MODEL APEX 800	GEX	2002-05-20
352899	1490085928	K020849	APEX 800 LASER SYSTEM, MODEL APEX 800	GEX	2002-05-20
43232	1312143717	K020374	OCULIGHT SL/SLX	HQF	2002-05-03
352899	1312143717	K020374	OCULIGHT SL/SLX	HQF	2002-05-03
43232	1409046899
352899	1409046899
43232	1912106514
352899	1912106514
43232	2048519352
352899	2048519352

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
GEX	34	2018-09-05
HQF	28	2023-02-23
HJO	2	1999-11-09
KYG	2	1998-02-19
HJK	2	1997-08-06
HMX	2	1997-05-20
MPA	2	1997-05-20

PMN#

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
2023-02-23
Iridex Corporation
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models)
2022-11-09
Iridex Corporation
Iridex 810 Laser
2022-03-23
Iridex Corporation
Iridex 810 Laser
2020-10-21
Iridex Corporation
Iridex TruFocus LIO Premiere
2018-09-05
Iridex Corporation
Iridex TruFocus LIO Premiere
2017-05-03
Iridex Corporation
IRIDEX Cyclo G6 Laser System, G-Probe Illuminate
2016-09-29
IRIDEX CORPORATION
IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID)
2015-01-02
IRIDEX CORPORATION
VARILITE LASER SYSTEM
2004-09-10
IRIDEX CORPORATION

GUDID#

Eye Safety Filter, Fixed (532 nm) - For use on the Moeller-Wedel DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (532 nm) - For use on the Leica M841 DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (532 nm) - For use on the Leica or Wild DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (532 nm) - For use on the Zeiss DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (577 nm) - For use on the Leica or Wild DovetailsOD3 @ 577 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (577 nm) - For use on the Zeiss DovetailsOD3 @ 577 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (532 nm) - For use on the Leica or Wild DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Two-Position (532 nm) - For use on the Zeiss DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (577 nm) - For use on the Leica Dovetails OD3 @ 577 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (532 nm) - For use on the Zeiss DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (577 nm) - For use on the Leica/Wild DovetailsOD3 @ 577 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (577 nm) - For use on the Zeiss DovetailsOD3 @ 577 nm
IRIDEX CORPORATION
2024-10-22
Eye Safety Filter, Fixed (810 nm) - For use on the Moeller-Wedel DovetailsOD3 @ 810 nm
IRIDEX CORPORATION
2024-10-21
Eye Safety Filter, Fixed (810 nm) - For use on the Leica M841 DovetailsOD3 @ 810 nm
IRIDEX CORPORATION
2024-10-21
Eye Safety Filter, Fixed (810 nm) - For use on the Zeiss DovetailsOD3 @ 810 nm
IRIDEX CORPORATION
2024-10-21
Eye Safety Filter, Fixed (810 nm) - For use on the Leica or Wild DovetailsOD3 @ 810 nm
IRIDEX CORPORATION
2024-10-21
Eye Safety Filter, Fixed (532 nm) - For use on the Topcon DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-21
Eye Safety Filter, Fixed (532 nm) - For use on the Leica or Wild DovetailsOD3 @ 532 nm
IRIDEX CORPORATION
2024-10-21
OMA (810 nm) - OMA, 810nm, for Zeiss Visu 150/200 Operating Microscope
IRIDEX CORPORATION
2024-05-06
OMA (810 nm) - OMA, 810 nm, for Leica/Wild M650/M690 Operating Microscope
IRIDEX CORPORATION
2024-05-06
OMA (810 nm) - OMA, 810 nm, for OPMI-6 Operating Microscope
IRIDEX CORPORATION
2024-05-06
SLA EasyView™ (577 nm) - for Haag Streit 900 BM/BQ Slit Lamp
IRIDEX CORPORATION
2024-05-06
SLA (577 nm) - for Zeiss 30 slit lamp or equivalent
IRIDEX CORPORATION
2024-05-06
SLA (532 nm) - for Zeiss 30 CSO or equivalent
IRIDEX CORPORATION
2024-05-06
SLA (810 nm) - SLA, 810 nm, for Haag Streit w/MM Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA EasyFit™ (532 nm) - SLA EasyFit™, 532nm, for Zeiss 30 & Split-Mirror Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA 50 µm (532 nm) - SLA 50 µm, 532nm, for Haag Streit 900 BQ w/MM Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA 50 µm (532 nm) - SLA 50 µm, 532 nm, for Haag Streit 900BQ Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA EasyView™ (532 nm) - SLA EasyView™ , 532 nm, for Haag Streit BM/BQ CSO Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA (810 nm) - SLA, 810 nm, for Haag Streit 900 BM Slit Lamp
IRIDEX CORPORATION
2024-05-02
SLA Standard (577 nm) - for Haag Streit 900 BM/BQ Slit Lamp or equivalent
IRIDEX CORPORATION
2024-05-02
SLA Standard (532 nm) - for Haag Streit BM/BQ CSO or equivalent
IRIDEX CORPORATION
2024-05-02
Iridex 577 Laser - The Iridex® 577 (577 nm, true-yellow) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave and MicroPulse® modes for ophthalmic applications.
IRIDEX CORPORATION
2024-01-18
Iridex 532 Laser - The Iridex® 532 (532, green) Laser Console is a solid-state laser that is used to deliver laser energy in Continuous-Wave for ear, nose and throat (ENT) applications, and in Continuous-Wave and MicroPulse® modes for ophthalmic applications.
IRIDEX CORPORATION
2024-01-18
TxCell for IQ577, Iridex Z 30 & CSO980 - TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)
IRIDEX CORPORATION
2022-08-01
TxCell for IQ577, H/S 900BM/BQ & CSO9900 - TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900
IRIDEX CORPORATION
2022-08-01
TxCell for IQ532, Iridex Z 30 & CSO9800 - TxCell Scanning Laser Delivery System for IQ532, Iridex Z30 & CSO9800 (without prism)
IRIDEX CORPORATION
2022-08-01
TxCell for IQ532, H/S 900BM/BQ & CSO9900 - TxCell Scanning Laser Delivery System for IQ532, H/S 900BM/BQ & CSO9900
IRIDEX CORPORATION
2022-08-01
Cyclo G6 Laser Console - 66245-1
IRIDEX CORPORATION
2022-02-16
IRIDEX 810 Laser - The Iridex 810 Laser is a semiconductor diode laser system that delivers pulsed 810nm infrared laser light intended to be used for the indication of retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, and other laser diode treatments.
IRIDEX CORPORATION
2021-03-10

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