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) (10) Instrument, Vitreous Aspiration And Cutting, Ac-Powered (HQE) (1)

Premarket Exempt

Clear

Vision One - 07290109143286 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Smart532 - 07290109143293 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Selecta Duet - 07290109143309 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Selecta Duet - 07290109143316 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LIO Keeler - 07290109143378 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX, HQE

Prescription Use : Yes

Device Count : 1

LaserLink Z - 07290109143385 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaserLink Z - 07290109143392 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Automatic Eye Safety Filter - 07290109143446 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LaserLink HS - 07290109143491 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Fixed Eye Safety Filter - 07290109143507 Catalog Number :

Device Class : 2

Duns Number: 043618763

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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