Iridex Corporation
Mountain View, CA, US
Iridex Corporation appears in FDA device records in Mountain View, CA. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Iridex Corporation carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Topcon Medical Laser Systems, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 28 510(k) clearances for Iridex Corporation between 1998 and 2023. The busiest year on record is 2002, with 3. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 3 |
| 2003 | 1 |
| 2004 | 2 |
| 2005 | 2 |
| 2006 | 3 |
| 2008 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 2 |
| 2018 | 2 |
| 2020 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230228 | Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) | HQF | Substantially Equivalent | |
| K223132 | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) | HQF | Substantially Equivalent | |
| K213592 | Iridex 810 Laser | HQF | Substantially Equivalent | |
| K202760 | Iridex 810 Laser | HQF | Substantially Equivalent | |
| K181662 | Iridex TruFocus LIO Premiere | GEX | Substantially Equivalent | |
| K180402 | PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar | HQF | Substantially Equivalent | |
| K171488 | PSLT for PASCAL Streamline | HQF | Substantially Equivalent | |
| K170718 | Iridex TruFocus LIO Premiere | GEX | Substantially Equivalent | |
| K162416 | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate | GEX | Substantially Equivalent | |
| K143154 | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) | GEX | Substantially Equivalent | |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | HQF | Substantially Equivalent | |
| K121475 | TXCELL SCANNING LASER DELIVERY SYSTEM | GEX | Substantially Equivalent | |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | HQF | Substantially Equivalent | |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | GEX | Substantially Equivalent | |
| K062074 | IRIDEX WIRELESS FOOTSWITCH | HQF | Substantially Equivalent | |
| K062369 | IRIDEX OCULIGHT TX | GEX | Substantially Equivalent | |
| K060905 | IRIDEX OTOPROBE LONG AND SHORT ANGLES, P/N 14310-1 AND 14320-1 | GEX | Substantially Equivalent | |
| K050562 | OCULIGHT GL/GLX | GEX | Substantially Equivalent | |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | GEX | Substantially Equivalent | |
| K040209 | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR | HQF | Substantially Equivalent | |
| K041930 | VARILITE LASER SYSTEM | GEX | Substantially Equivalent | |
| K031665 | IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS | HQF | Substantially Equivalent | |
| K022228 | FAMILY OF IRIS MEDICAL ENDOPROBE HANDPIECES | GEX | Substantially Equivalent | |
| K020849 | APEX 800 LASER SYSTEM, MODEL APEX 800 | GEX | Substantially Equivalent | |
| K020374 | OCULIGHT SL/SLX | HQF | Substantially Equivalent | |
| K992298 | IRIDERM, MODEL APEX 800 | GEX | Substantially Equivalent | |
| K982031 | OCULIGHT GL WITH THE DERMATOLOGY HANDPIECE | GEX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2939653 | 2939653 | Iridex Corporation | 1212 Terra Bella Avenue, MOUNTAIN VIEW, CA 94043 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HJOBiomicroscope, Slit-Lamp, Ac-Powered
- HMXCannula, Ophthalmic
- KYGDevice, Irrigation, Ocular Surgery
- MPAEndoilluminator
- MDMInstrument, Manual, Surgical, General Use
- HQFLaser, Ophthalmic
- HJKLens, Contact, Polymethylmethacrylate, Diagnostic
- GEXPowered Laser Surgical Instrument
- HOSProjector, Ophthalmic
- HRJTable, Instrument, Powered, Ophthalmic
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1075-2018 | 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 patient s retina. It allows binocular visualization of the peripheral retina and can be used to evaluate and treat patients. | It was discovered that the laser energy was not going where intended to put it, resulting in focal cataracts and iris burns. | Class II | Terminated | |
| Z-2405-2016 | Opthalmic: PASCAL Synthesis is an ophthalmic scanning laser system. The system can perform single shot photocoagulation as is performed conventionally. | Topcon discovered an anomaly with titration, only when EpM is turned on during the titration process. This event may occur if the user turns on EpM, turns off the Landmark (LM) function (with any EpM supported pattern) and then enters titration mode. | Class II | Terminated | |
| Z-1774-2013 | PASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye. | When using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain