LUMENIS LTD.

LUMENIS LTD.

Address:6 HAKIDMA STREET PO BOX 240,YOKNEAM Northern,IL

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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

No

Clear

Slimline 200 Fiber - 07290109140001 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline 365 Fiber - 07290109140018 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline 550 Fiber - 07290109140025 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline 1000 Fiber - 07290109140032 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Duotome Sidelite 550 Fiber - 07290109140049 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline Sterilization Tray - 07290109140124 Catalog Number :

Device Class :

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Slimline EZ 200 Fiber - 07290109140162 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline EZ 365 Fiber - 07290109140179 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline EZ 550 Fiber - 07290109140186 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Slimline EZ SIS 200 Fiber - 07290109140193 Catalog Number :

Device Class : 2

Duns Number: 600166524

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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