OPTIMEDICA CORPORATION

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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

Ophthalmic femtosecond laser (OOE) (6)

Premarket Exempt

Clear

LIQUID OPTICS INTERFACE - 05050474604803 Catalog Number : LOI

Device Description : LIQUID OPTICS(TM) INTRFACE, STERILE, SGL

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

LIQUID OPTICS INTERFACE - 05050474604810 Catalog Number : LOI-12

Device Description : SINGLE LIQUID OPTICS INTERFACE,12

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

LIQUID OPTICS INTERFACE - 05050474604827 Catalog Number : LOI-BP

Device Description : LIQUID OPTICS INTRFC,STERILE, BULK PK,20

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

LIQUID OPTICS INTERFACE - 05050474604834 Catalog Number : LOI-12-BP

Device Description : LIQUID OPTICS INTRFCE,12,BK PK,20 UNITS

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

CATALYS SYSTEM - 05050474609792 Catalog Number : CATALYS-U

Device Description : CATALYS SYSTEM, US

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

CATALYS SYSTEM - 05050474709508 Catalog Number : 0160-9500

Device Description : CATALYS ELEVATED SYS ACCY,USE W/MPB,US

Device Class : 2

Duns Number: 151018996

Premarket Exempt : No

Product Code : OOE

Prescription Use : Yes

Device Count : 1

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