AZENA MEDICAL, LLC

AZENA MEDICAL, LLC

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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

Lamp, Infrared, Therapeutic Heating (ILY) (9) Powered Laser Surgical Instrument (GEX) (8) Laser, Dental, Soft Tissue (NVK) (6)

Premarket Exempt

No

Clear

Gemini EVO - 00850010501062 Catalog Number :

Device Description : Gemini EVO Domestic Laser

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501079 Catalog Number :

Device Description : Gemini EVO International Laser

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501086 Catalog Number :

Device Description : Gemini EVO Demo Laser Unit

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501093 Catalog Number : G2-5-007

Device Description : Refill accessory for Gemini EVO kit

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501109 Catalog Number : G2-5-008

Device Description : Refill accessory for Gemini EVO laser

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501116 Catalog Number : G2-5-004

Device Description : Refill/accessory for power supply for Gemini EVO

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

Gemini EVO - 00850010501123 Catalog Number : G2-5-005

Device Description : Refill/accessory for International Power supply for Gemini EVO

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

GEMINI EVO - 00850010501130 Catalog Number : G2-5-006

Device Description : Refill/accessory for Gemini EVO laser handpiece shell

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : NVK, GEX, ILY

Prescription Use : Yes

Device Count : 1

Gemini 810+980 Diode Laser - 00861407000303 Catalog Number :

Device Description : Dual wavelength super-pulsed dental soft tissue diode laser

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Gemini 810+980 Diode Laser Kit, International - 00861407000389 Catalog Number :

Device Class : 2

Duns Number: 073483242

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

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