Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
K-Number: K230228 · 2023-02-23
Device Summary
Frequently Asked Questions
What is the Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Iridex Corporation. The 510(k) number is K230228.
When did Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) receive FDA 510(k) clearance?
Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230228.
Who is the listed applicant for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?
The FDA 510(k) record lists Iridex Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?
The FDA product code for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is HQF.
Other records listing Iridex Corporation as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: HQF)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.