LUMENIS INC.

Address:1870 S Milestone Dr,SALT LAKE CITY,UT,84104,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

Powered Laser Surgical Instrument (GEX) (9) Laser, Ophthalmic (HQF) (1)

Premarket Exempt

Clear

Acculite EndoOto - 07290109140827 Catalog Number :

Device Class :

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Acculite EndoOto - 07290109140834 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Acculite EndoOto - 07290109140841 Catalog Number :

Device Class :

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Acculite EndoOto - 07290109140858 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Acculite EndoOcular - 07290109142784 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : HQF

Prescription Use : Yes

Device Count : 1

Selecta II - 07290109143231 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Novus Spectra - 07290109143248 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Selecta Duet - 07290109143255 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaserLink S - 07290109143262 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Novus Spectra - 07290109143279 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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