RAINTREE ESSIX INC.

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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) (10) Powered laser surgical instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

Sculpt I.Q. - D74666591841 Catalog Number : 6659184

Device Description : Handpiece sleeve with keypad

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666591921 Catalog Number : 6659192

Device Description : Optic protection cap for handpiece (5 pieces)

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 5

Sculpt I.Q. - D74666592001 Catalog Number : 6659200

Device Description : EasyBend - Bending tool

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666592181 Catalog Number : 6659218

Device Description : Fibercutter

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666592261 Catalog Number : 6659226

Device Description : Laser protective goggles

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666592341 Catalog Number : 6659234

Device Description : Laser protective goggles for spectacle wearers

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666592421 Catalog Number : 6659242

Device Description : Laser protective goggle for patient

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Sculpt I.Q. - D74666592831 Catalog Number : 6659283

Device Description : EasyTip 320 Pack 25

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 25

Sculpt I.Q. - D74666592911 Catalog Number : 6659291

Device Description : EasyTip Endo Pack 25

Device Class :

Duns Number: 801157132

Premarket Exempt : No

Product Code : ILY, GEX

Prescription Use : Yes

Device Count : 25

Sculpt I.Q. - D74666593091 Catalog Number : 6659309

Device Description : MultiTip 8mm, therapy light guide

Device Class : 2

Duns Number: 801157132

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

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