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

Powered Laser Surgical Instrument (GEX) (9) Laser, Ophthalmic (HQF) (1)

Premarket Exempt

No Yes

Clear

Zeiss Dovetail 577nm ESF - 00813125015053 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

G-Probe™ RFID Single - 00813125015220 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

G-Probe™ RFID Box of 6 - 00813125015237 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MicroPulse® P3 Device Box of 6 - 00813125015244 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

MicroPulse® P3 Device Single - 00813125015251 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

TxCell for IQ577, Iridex Z 30 & CSO980 - 00813125015282 Catalog Number :

Device Description : TxCell Scanning Laser Delivery System for IQ577, Iridex Z 30 & CSO980 (without prism)

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

TxCell for IQ577, H/S 900BM/BQ & CSO9900 - 00813125015305 Catalog Number :

Device Description : TxCell Scanning Laser Delivery System for IQ577, H/S 900BM/BQ & CSO9900

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

TxCell for IQ532, Iridex Z 30 & CSO9800 - 00813125015312 Catalog Number :

Device Description : TxCell Scanning Laser Delivery System for IQ532, Iridex Z30 & CSO9800 (without prism)

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

TxCell for IQ532, H/S 900BM/BQ & CSO9900 - 00813125015336 Catalog Number :

Device Description : TxCell Scanning Laser Delivery System for IQ532, H/S 900BM/BQ & CSO9900

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

G-Probe™ Illuminate Box of 6 - 00813125015350 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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