FDA 510(k) Applications Submitted by IRIDEX CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K202760 09/21/2020 Iridex 810 Laser Iridex Corporation
K223132 10/03/2022 Iridex PASCAL« 532, Iridex PASCAL« 577, Iridex PASCAL« (532nm and 577 nm models) Iridex Corporation
K213592 11/12/2021 Iridex 810 Laser Iridex Corporation
K181662 06/25/2018 Iridex TruFocus LIO Premiere Iridex Corporation
K170718 03/09/2017 Iridex TruFocus LIO Premiere Iridex Corporation
K041930 07/19/2004 VARILITE LASER SYSTEM IRIDEX CORPORATION
K162416 08/30/2016 IRIDEX Cyclo G6 Laser System, G-Probe Illuminate IRIDEX CORPORATION
K230228 01/27/2023 Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) Iridex Corporation
K143154 11/03/2014 IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) IRIDEX CORPORATION


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