Company · US
Iridex Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1998 to 2023. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 2023 | K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) Iridex Corporation | HQF |
| Nov 9, 2022 | K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) Iridex Corporation | HQF |
| Mar 23, 2022 | K213592 | Iridex 810 Laser Iridex Corporation | HQF |
| Oct 21, 2020 | K202760 | Iridex 810 Laser Iridex Corporation | HQF |
| Sep 5, 2018 | K181662 | Iridex TruFocus LIO Premiere Iridex Corporation | GEX |
| May 3, 2017 | K170718 | Iridex TruFocus LIO Premiere Iridex Corporation | GEX |
| Sep 29, 2016 | K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate Iridex Corporation | GEX |
| Jan 2, 2015 | K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) Iridex Corporation | GEX |
| Nov 28, 2012 | K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM Iridex Corp | GEX |
| Aug 7, 2008 | K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS Iridex Corp | GEX |
| Nov 14, 2006 | K062074 | IRIDEX WIRELESS FOOTSWITCH Iridex Corp | HQF |
| Nov 8, 2006 | K062369 | IRIDEX OCULIGHT TX Iridex Corp | GEX |
| May 31, 2006 | K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 Iridex Corp | GEX |
| Apr 14, 2005 | K050562 | OCULIGHT GL/GLX Iridex Corp | GEX |
| Sep 20, 2004 | K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR Iridex Corp | HQF |
| Sep 10, 2004 | K041930 | VARILITE LASER SYSTEM Iridex Corporation | GEX |
| Aug 27, 2003 | K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS Iridex Corp | HQF |
| Oct 8, 2002 | K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES Iridex Corp | GEX |
| May 20, 2002 | K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 Iridex Corp | GEX |
| May 3, 2002 | K020374 | OCULIGHT SL/SLX Iridex Corp | HQF |
| Dec 9, 1999 | K992298 | IRIDERM, MODEL APEX 800 Iridex Corp | GEX |
| Sep 8, 1998 | K982031 | OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE Iridex Corp | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2018 | Iridex Corporation Iridex TruFocus LIO Premiere" Laser Indirect Ophthalmoscope ( LIO )
The LIO is a headmounted indirect ophthalmoscope which is used with a handheld lens to view and perform laser treatments on a pat Terminated |
GEX | K170718 |