IRIDEX CORPORATION

IRIDEX CORPORATION

Address:1212 Terra Bella Avenue,MOUNTAIN VIEW,CA,94043,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Laser, Ophthalmic (HQF) (10)

Premarket Exempt

No Yes

Clear

Wireless Footswitch Power Adjust - 00813125010096 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Footswitch Half Assembly - 00813125010102 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

ASSY FOOTSWITCH PACKAGED - 00813125010119 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Safety Filter 810nm Zeiss Dovetail - 00813125010140 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Safety Filter 810nm Leica/Wild Dovetail - 00813125010157 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Safety Filter 532 nm Topcon OMS 300/320 - 00813125010218 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Safety Filter 532nm Zeiss Dovetail - 00813125010225 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Safety Filter 532nm Leica/Wild Dovetail M650/M690 - 00813125010232 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Assy Illumination Adapter PHOTON - 00813125010928 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

SLA 532nm EasyFit Zeiss 30 - 00813125011130 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

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