Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
Iridex Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| Iridex Corporation | 5 | N | 2026-01-01 | 5215 Hellyer Avenue Suite 150 San Jose CA US 95138 | ||
| 2939653 | 2939653 | Iridex Corporation | 1 | N | 2026-01-01 | 1212 Terra Bella Avenue MOUNTAIN VIEW CA US 94043 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 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 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 43232 | 1060817934 | K992836 | SL990, SL980, SL950 | HJO | 1999-11-09 |
| 352899 | 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 |
| 352899 | 1257355369 | K971853 | ENDOVIEW SPPHIRE LENS SET | HJK | 1997-08-06 |
| 43232 | 1257355369 | K971853 | ENDOVIEW SPPHIRE LENS SET | HJK | 1997-08-06 |
| 352899 | 1759631260 | K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | MPA | 1997-05-20 |
| 43232 | 1759631260 | K970875 | ENDOLIGHT FIBEROPTIC ENDO-ILLUMINATOR (20 GA. & 19 GA.) | MPA | 1997-05-20 |
| 352899 | 1618401029 | K970873 | ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.) | HMX | 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 |
| 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 |
| 352899 | 1099537372 | K202760 | Iridex 810 Laser | HQF | 2020-10-21 |
| 43232 | 1099537372 | K202760 | Iridex 810 Laser | HQF | 2020-10-21 |
| 352899 | 1434313153 | K181662 | Iridex TruFocus LIO Premiere | GEX | 2018-09-05 |
| 43232 | 1434313153 | K181662 | Iridex TruFocus LIO Premiere | GEX | 2018-09-05 |
| 352899 | 1847379015 | K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | HQF | 2018-05-25 |
| 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 |
| 352899 | 1727649601 | K171488 | PSLT for PASCAL Streamline | HQF | 2017-11-27 |
| 352899 | 1954731106 | K170718 | Iridex TruFocus LIO Premiere | GEX | 2017-05-03 |
| 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 |
| 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 |
| 352899 | 1031634028 | K123056 | PASCAL LASER INDIRECT OPHTHALMOSCOPE | HQF | 2012-11-13 |
| 43232 | 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 |
| 43232 | 1275963967 | K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | HQF | 2011-08-11 |
| 352899 | 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 |
| 352899 | 1847147784 | K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | GEX | 2008-08-07 |
| 43232 | 1847147784 | K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | GEX | 2008-08-07 |
| 352899 | 1381430993 | K062369 | IRIDEX OCULIGHT TX | GEX | 2006-11-08 |
| 43232 | 1381430993 | K062369 | IRIDEX OCULIGHT TX | GEX | 2006-11-08 |
| 352899 | 1064481340 | K062336 | OPTIMEDICA LASER INDIRECT OPHTHALMOSCOPE | GEX | 2006-10-19 |
| 43232 | 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 |
| 352899 | 1598092951 | K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | GEX | 2005-03-03 |
| 43232 | 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 |
| 352899 | 1799551584 | K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | HQF | 2003-08-27 |
| 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 |
| 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 |
| 352899 | 1409046899 | ||||
| 43232 | 1409046899 | ||||
| 43232 | 1912106514 | ||||
| 352899 | 1912106514 | ||||
| 352899 | 2048519352 | ||||
| 43232 | 2048519352 |
Iridex Corporation
Iridex Corporation
Iridex Corporation
Iridex Corporation
Iridex Corporation
Iridex Corporation
IRIDEX CORPORATION
IRIDEX CORPORATION
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORPORATION
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
IRIDEX CORP.
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-22
2024-10-21
2024-10-21
2024-10-21
2024-10-21
2024-10-21
2024-10-21
2024-05-06
2024-05-06
2024-05-06
2024-05-06
2024-05-06
2024-05-06
2024-05-02
2024-05-02
2024-05-02
2024-05-02
2024-05-02
2024-05-02
2024-05-02
2024-05-02
2024-01-18
2024-01-18
2022-08-01
2022-08-01
2022-08-01
2022-08-01
2022-02-16
2021-03-10