LIGHT INSTRUMENTS LTD

Address:4 Hatnufa Street,Yokneam Northern,IL

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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) (10)

Premarket Exempt

Clear

LiteTouch - 07290016784015 Catalog Number : LI-FG0012A

Device Description : The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue den The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral and maxillofacial surgery and dentistry.This product is a kit that contains consul,applicator and an accessory kit.

Device Class : 2

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

LiteTouch Applicator - 07290016784022 Catalog Number : LI-FG0015A

Device Description : YAG Laser Applicator. LiteTouch Applicator.

Device Class : 2

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

E1 Handpiece, LT - 07290016784107 Catalog Number : AS78251

Device Description : Handpiece for the LightTouch system.

Device Class : 2

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Straight Handpiece, LT - 07290016784114 Catalog Number : AS72301

Device Description : Strait Hanpiece for the LightTouch system.

Device Class : 2

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

TIP for LITETOUCH - 07290016784206 Catalog Number : LI-AS30040

Device Description : Package of 5 reusable tips for the LiteTouch system.

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

TIP for LITETOUCH - 07290016784213 Catalog Number : LI-AS30050

Device Description : Package of 5 reusable tips for the LiteTouch system.

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

TIP for LITETOUCH - 07290016784305 Catalog Number : AS75651

Device Description : Package of 5 reusable tips for the LiteTouch system

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

TIP for LITETOUCH - 07290016784312 Catalog Number : AS70752

Device Description : Package of 5 reusable tips for the LiteTouch system

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

TIP for LITETOUCH - 07290016784329 Catalog Number : AS70722

Device Description : Package of 5 reusable tips for the LiteTouch system

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

TIP for LITETOUCH - 07290016784336 Catalog Number : AS70742

Device Description : Package of 5 reusable tips for the LiteTouch system

Device Class :

Duns Number: 514489314

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 5

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