Iridex 810 Laser
K-Number: K213592 · 2022-03-23
ApplicantIridex Corporation
Decision Date2022-03-23
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent
Device Summary
Iridex 810 Laser is a medical device manufactured by Iridex Corporation. It received FDA 510(k) clearance on 2022-03-23 under approval number K213592. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Iridex 810 Laser?
Iridex 810 Laser is a medical device that received FDA 510(k) clearance on 2022-03-23. It is manufactured by Iridex Corporation. The 510(k) number is K213592.
When was Iridex 810 Laser approved by the FDA?
Iridex 810 Laser received FDA 510(k) clearance on 2022-03-23, under approval number K213592.
What company makes Iridex 810 Laser?
Iridex 810 Laser is manufactured by Iridex Corporation.
What is the FDA product code for Iridex 810 Laser?
The FDA product code for Iridex 810 Laser is HQF.
Other Devices by Iridex Corporation
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K170718Iridex TruFocus LIO Premiere
K181662Iridex TruFocus LIO Premiere
K202760Iridex 810 Laser
K223132Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
K230228Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
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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.