LAMBDA SPA

Address:via dell impresa 1,Brendola Vicenza,IT

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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) (8) Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) (HOY) (2)

Premarket Exempt

Clear

Doctor Diode Laser - 08056093611021 Catalog Number : LATSU302.4

Device Description : Doctor Diode Laser/ Optical Tip LATSU302.4 (Doctor Smile - Wiser Tip) is used i

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Diode Laser - 08056093611038 Catalog Number : LATIM302.4

Device Description : Doctor Diode Laser/ Optical Tip LATIM302.4 (Doctor Smile - Wiser Tip) is used i

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Diode Laser - 08056093611045 Catalog Number : LATHE402.4

Device Description : Doctor Diode Laser/Optical Tip LATHE402.4 (Doctor Smile - Wiser Tip) is used in

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Smile - 08056093611052 Catalog Number : LAFIO002.3

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Smile - 08056093611069 Catalog Number : LAFIO003.3

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Smile - 08056093611076 Catalog Number : LAFIO0042.3

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Smile - 08056093611083 Catalog Number : LAFIO006.3

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Doctor Smile / Doctor Diode Laser - 08056093611090 Catalog Number : LOEYW002.0

Device Description : Eye protection (LOEYW002.0) against laser light at 980 nm

Device Class : 1

Duns Number: 428482616

Premarket Exempt : No

Product Code : HOY

Prescription Use : Yes

Device Count : 1

Doctor Smile / Doctor Diode Laser - 08056093611106 Catalog Number : LOEYW004.0

Device Description : Eye protection (LOEWY 004.0) against laser light at 810 nm

Device Class : 1

Duns Number: 428482616

Premarket Exempt : No

Product Code : HOY

Prescription Use : Yes

Device Count : 1

Doctor Diode Laser - 08056093611113 Catalog Number : LATNT601.10

Device Class : 2

Duns Number: 428482616

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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