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) (9) Powered Laser Surgical Instrument (GEX) (6)

Premarket Exempt

No Yes

Clear

PASCAL Synthesis, 532nm - 00813125015527 Catalog Number : SA-06284

Device Description : (532) Console PA-03, Synthesis III (Packed) IRIDEX

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis, 577nm - 00813125015534 Catalog Number : SA-06285

Device Description : (577) Console PA-03, Synthesis III (Packed) IRIDEX

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF, GEX

Prescription Use : Yes

Device Count : 1

Scanner, TxCell Z120/577 - 00813125015558 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis TwinStar (577nm/638nm) - 00813125015589 Catalog Number : SA-06288

Device Description : PASCAL Synthesis TwinStar (577/638) Console, PA-03, Synthesis III (Packed) IRIDEX

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis TwinStar (577nm/638nm) - 00813125015596 Catalog Number : SA-06452

Device Description : Pascal Synthesis III Twinstar, PA-04, CB-8, 577/638, Packed IRIDEX

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

PASCAL Synthesis, 532nm - 00813125015602 Catalog Number : SA-06454

Device Description : Pascal Synthesis III, PA-04, CB-8, 532 (Packed) IRIDEX

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : GEX, HQF

Prescription Use : Yes

Device Count : 1

ML LIO+ w/Heine Headset Dual wavelength OMEGA 500 - 00813125015619 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

RFID LIO+ 532nm w/Heine Omega Headband - 00813125015626 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

LIO+810 w/Heine Headset IR LIO w/ Omega 500 Head set - 00813125015633 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Assy Final HS SLA IQ532 Standard Mount - 00813125015640 Catalog Number :

Device Class : 2

Duns Number: 612920785

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

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