COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL

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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

Biomicroscope, Slit-Lamp, Ac-Powered (HJO) (7) Tonometer, Manual (HKY) (2) Camera, Ophthalmic, Ac-Powered (HKI) (1) System, Image Management, Ophthalmic (NFJ) (1)

Premarket Exempt

Clear

S4 OPTIK - 08056098470227 Catalog Number : 100258A50.D V0

Device Description : SLIT LAMP SL9800 3X DIGITAL

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470234 Catalog Number : 100258A50.J V0

Device Description : SLIT LAMP SL9800 5X

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470258 Catalog Number : 100258A50.D V0

Device Description : SLIT LAMP SL990 ELITE

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

IRIDEX - 08056098470265 Catalog Number : 100270A50.E V1

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

IRIDEX - 08056098470272 Catalog Number : 1002072A50.E V1

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470319 Catalog Number : 103303A00 V0/S10

Device Description : COBRA FUNDUS CAMERA

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : NFJ, HKI

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470425 Catalog Number : 102002100.S

Device Description : APPLANATION TONOMETER

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470517 Catalog Number : 102002200.S

Device Description : APPLANATION TONOMETER

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HKY

Prescription Use : No

Device Count : 1

S4 OPTIK - 08056098470647 Catalog Number : 100250A50.J V0

Device Description : SLIT LAMP SL990 5X YELLOW FILTER+REHOSTAT

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

IRIDEX - 08056098470654 Catalog Number : 100213A50.E V1

Device Class : 2

Duns Number: 432448470

Premarket Exempt : No

Product Code : HJO

Prescription Use : No

Device Count : 1

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