Convergent Laser Technologies

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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) (10)

Premarket Exempt

Clear

Optilite - 00855430006302 Catalog Number :

Device Description : 1000 micron circular 90 degree internal reflection fiber assembly w/ gold cap

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006319 Catalog Number :

Device Description : 1000 micron holmium fiber assembly with flat tip

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006326 Catalog Number :

Device Description : 200 micron holmium fiber assembly with flat tip

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006333 Catalog Number :

Device Description : 400 micron holmium fiber assembly with flat tip

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006340 Catalog Number :

Device Description : 600 micron holmium fiber assembly with flat tip

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006357 Catalog Number :

Device Description : 600 micron angled delivery holmium fiber assembly with quartz cap

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006364 Catalog Number :

Device Description : Test Fiber-optic, 200 micron

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006371 Catalog Number :

Device Description : Test Fiber-optic, 400 micron

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006388 Catalog Number :

Device Description : Test Fiber-optic, 600 micron

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Optilite - 00855430006395 Catalog Number :

Device Description : Odyssey 30 Holmium Laser System

Device Class : 2

Duns Number: 177735305

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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