Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)— 510(k) K230228
Substantially EquivalentIridex Corporation
FDA 510(k) clearance K230228 for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models), Substantially Equivalent on 2023-02-23. Applicant: Iridex Corporation. Device class: 2.
Clearance details
- Applicant
- Iridex Corporation
- Product code
- Code HQF
- Device class
- Class 2
- Regulation
- 21 CFR 886.4390
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code HQF
view allMore clearances from Iridex Corporation
view allAdverse events under product code HQF
product code HQF- Injury
- 166
- Other
- 1
- Total
- 167
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.