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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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