ALMA LASERS LTD.

Address:18 Haharash Street,CAESAREA 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

Electrosurgical, Cutting & Coagulation & Accessories (GEI) (5) Powered Laser Surgical Instrument (GEX) (5)

Premarket Exempt

Yes No

Clear

Ultra V UltraBody Handpiece - 17290110120204 Catalog Number : AAUN27121004

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ultra V Ultraface Handpiece - 17290110120211 Catalog Number : AAUN27121006

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ultra V UniBody Handpiece - 17290110120228 Catalog Number : AAUN27121003

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ultra V Uniface Handpiece - 17290110120235 Catalog Number : AAUN27121005

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Ultra V Unilarge Thermometer Handpiece - 17290110120242 Catalog Number : AAUN27121001

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEI

Prescription Use : No

Device Count : 1

Handpiece Cooled 515 (3) for Harmony XL 50000 pulses - 17290110120259 Catalog Number : AAHP01050801

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Handpiece Cooled 540 (3) for Harmony XL 50000 pulses - 17290110120266 Catalog Number : AAHP01050802

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Handpiece cooled 540 VL (3) For Lite Pro - 17290110120273 Catalog Number : AAIP25121104

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Handpiece Cooled 570 (3) for Harmony XL 50000 pulses - 17290110120280 Catalog Number : AAHP01050803

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Handpiece cooled 570 SR/SSR (3) For Lite Pro - 17290110120297 Catalog Number : AAIP25121105

Device Class : 2

Duns Number: 532283264

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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