AMD Lasers

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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)

Premarket Exempt

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Quadra Tip - 00851759007105 Catalog Number : QT

Device Description : Quadra whitening tip for use with the the Picasso or Picasso Plus soft-tissue de Quadra whitening tip for use with the the Picasso or Picasso Plus soft-tissue dental laser. Compatible with the multi-tip handpiece (MTHP).

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Multi-Tip Handpiece - Picasso (Orange) - 00851759007112 Catalog Number : STF400

Device Description : Multi-tip handpiece (MTHP) for use with the Picasso soft-tissue dental laser. Th Multi-tip handpiece (MTHP) for use with the Picasso soft-tissue dental laser. This multi-tip handpiece has an orange jacket.

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Multi-Tip Handpiece - Picasso Lite (Black) - 00851759007129 Catalog Number : STF200

Device Description : Multi-tip handpiece (MTHP) for use with the Picasso Lite soft-tissue dental lase Multi-tip handpiece (MTHP) for use with the Picasso Lite soft-tissue dental laser. This multi-tip handpiece has an black jacket.

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

400um Strippable Fiber - FC Connection - 00851759007136 Catalog Number : SF400-FC

Device Description : 400um strippable fiber for use with the Picasso or Picasso Lite soft-tissue dent 400um strippable fiber for use with the Picasso or Picasso Lite soft-tissue dental lasers. The strippable fiber has an orange strain relief and an FC connector.

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

400um Strippable Fiber - Plus Series - 00851759007143 Catalog Number : SF400-PLUS

Device Description : 400um strippable fiber for use with the Picasso Plus or Picasso Lite Plus soft-t 400um strippable fiber for use with the Picasso Plus or Picasso Lite Plus soft-tissue dental lasers. The strippable fiber has a blue strain relief.

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

400um Strippable Fiber - ST Connection - 00851759007150 Catalog Number : SF400-ST

Device Description : 400um strippable fiber for use with the Picasso soft-tissue dental lasers. The s 400um strippable fiber for use with the Picasso soft-tissue dental lasers. The strippable fiber has a black strain relief and an ST connection for legacy Picasso units.

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Laser Safety Goggles (Sport Frame) - 00851759007167 Catalog Number : EYE

Device Description : Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Laser Safety Goggles (fit-over frame) - 00851759007174 Catalog Number : EYEF

Device Description : Laser Safety Sport Fit-Over Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 P Laser Safety Sport Fit-Over Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard

Device Class : 2

Duns Number: 080354039

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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