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Iridex Corporation

FDA 510(k) & PMA Approved Devices — 7 products

Total Devices7
Categories2
Latest FDA decision2023-02-23
TypeNumberDevice NameCodeDateActions
510(k) K230228 Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)HQF2023-02-23 View
510(k) K223132 Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)HQF2022-11-09 View
510(k) K213592 Iridex 810 LaserHQF2022-03-23 View
510(k) K202760 Iridex 810 LaserHQF2020-10-21 View
510(k) K181662 Iridex TruFocus LIO PremiereGEX2018-09-05 View
510(k) K170718 Iridex TruFocus LIO PremiereGEX2017-05-03 View
510(k) K162416 IRIDEX Cyclo G6 Laser System, G-Probe IlluminateGEX2016-09-29 View
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