# Iridex Corp

- Location (FDA's records): Mountain View, CA
- FDA decisions: 22 (1998–2023): 22 510(k) clearances
- Names in FDA's records: Iridex Corp (13); Iridex Corporation (9)
- Product codes: GEX (14), HQF (8)
- 510(k) review time since 2016: median 37 days, against 86 for FDA's reviews in the same codes and years (6 of 7 faster)
- Predicates its devices cite: 63 (20 its own); citations of its devices by later devices: 46 (20 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Iriderm Div.: 7 (https://510kreport.com/company/iriderm-div)
- Ceram Optec, Inc.: 4 (https://510kreport.com/company/ceram-optec)
- Laserscope: 3 (https://510kreport.com/company/laserscope)
- Lumenis, Inc.: 3 (https://510kreport.com/company/lumenis)
- Cynosure, Inc.: 3 (https://510kreport.com/company/cynosure)
- Nidek, Inc.: 2 (https://510kreport.com/company/nidek)
- Alcon Laboratories: 2 (https://510kreport.com/company/alcon-laboratories)
- Topcon Medical Laser Systems, Inc.: 2 (https://510kreport.com/company/topcon-medical-laser-systems)

## Firms that cite its devices most
- Quantel Medical: 5 (https://510kreport.com/company/quantel-medical)
- Topcon Medical Laser Systems, Inc.: 3 (https://510kreport.com/company/topcon-medical-laser-systems)
- Lightmed Corp.: 3 (https://510kreport.com/company/lightmed)
- Spectragenics, Inc.: 3 (https://510kreport.com/company/spectragenics)
- Lumenis, Inc.: 2 (https://510kreport.com/company/lumenis)
- Od-Os GmbH: 2 (https://510kreport.com/company/od-os)
- Katalyst Surgical, LLC: 1 (https://510kreport.com/company/katalyst-surgical)
- Hoya Conbio, Inc.: 1 (https://510kreport.com/company/hoya-conbio)

## Its most-cited devices
- K071687: Famili of Iridex IQ Laser Systems (2008), cited by 13
- K020374: Oculight SL/SLX (2002), cited by 9
- K041930: Varilite Laser System (2004), cited by 3
- K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID) (2015), cited by 3
- K031665: Iris Medical Oculight GL/GLX Laser Systems (2003), cited by 3
- K020849: Apex 800 Laser System, Model Apex 800 (2002), cited by 3

## Recent decisions
- K230228: Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (Feb 23, 2023)
- K223132: Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) (Nov 9, 2022)
- K213592: Iridex 810 Laser (Mar 23, 2022)
- K202760: Iridex 810 Laser (Oct 21, 2020)
- K181662: Iridex TruFocus LIO Premiere (Sep 5, 2018)
- K170718: Iridex TruFocus LIO Premiere (May 3, 2017)
- K162416: IRIDEX Cyclo G6 Laser System, G-Probe Illuminate (Sep 29, 2016)
- K143154: IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe (RFID) (Jan 2, 2015)

Source page: https://510kreport.com/company/iridex