Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228)
Description
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) by Iridex Corporation, an FDA 510(k) cleared ophthalmic device.
Regulatory Information
FDA Database
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Predicate lineage for K230228
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) (K230228) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K071687 | FAMILI OF IRIDEX IQ LASER SYSTEMS | Iridex Corp | 2008 |
Trace the full predicate network for K230228
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.