Iridex Corporation

Matched from indexed company URL: IRIDEX CORPORATION

FDA Registration(s)

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

GUDID Contact Samples

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

Source GUDID	Product	Phone	Email
00813125010249	Eye Safety Filter, Fixed (532 nm) - For use on the Moeller-Wedel Dovetails OD3 @ 532 nm	(800) 388-4747	techsupport@iridex.com
00813125010256	Eye Safety Filter, Fixed (532 nm) - For use on the Leica M841 Dovetails OD3 @ 532 nm	(800) 388-4747	techsupport@iridex.com

iridex.com

Registered Device Listings

Registration key	Listing key	Premarket submission	Device	Product code	Decision date
43232	1060817934	K992836	SL990, SL980, SL950	HJO	1999-11-09
43232	1869272924	K992298	IRIDERM, MODEL APEX 800	GEX	1999-12-09
43232	1147506939	K974561	MOISTAIR FLUID AIR TUBING SET	KYG	1998-02-19
43232	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
43232	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
43232	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
43232	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
43232	1727649601	K171488	PSLT for PASCAL Streamline	HQF	2017-11-27
43232	1954731106	K170718	Iridex TruFocus LIO Premiere	GEX	2017-05-03
43232	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
43232	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
43232	1031634028	K123056	PASCAL LASER INDIRECT OPHTHALMOSCOPE	HQF	2012-11-13
43232	2017374054	K121475	TXCELL SCANNING LASER DELIVERY SYSTEM	GEX	2012-11-28
43232	1275963967	K111108	PASCAL STREAMLINE 577 (WITH ACCESSORIES)	HQF	2011-08-11
43232	1601191365	K100019	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2010-05-04
43232	1366591561	K092621	PASCAL STREAMLINE PHOTOCOAGULATOR	HQF	2009-09-25
43232	1485342515	K091666	PASCAL PHOTOCOAGULATOR, PASCAL-US	GEX	2009-07-15
43232	1648737664	K081744	PASCAL SYNTHESIS DELIVERY SYSTEM	GEX	2008-09-09
43232	1847147784	K071687	FAMILI OF IRIDEX IQ LASER SYSTEMS	GEX	2008-08-07
43232	1381430993	K062369	IRIDEX OCULIGHT TX	GEX	2006-11-08
43232	1064481340	K062336	OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE	GEX	2006-10-19
43232	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
43232	1549937890	K050562	OCULIGHT GL/GLX	GEX	2005-04-14
43232	1598092951	K043486	PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01	GEX	2005-03-03
43232	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
43232	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
43232	1312143717	K020374	OCULIGHT SL/SLX	HQF	2002-05-03
43232	1409046899
43232	1912106514
43232	2048519352