LiteTouch LI-FG0012A

GUDID 07290016784015

The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral

LIGHT INSTRUMENTS LTD

Dental solid-state laser system

• Primary Device ID: 07290016784015
• NIH Device Record Key: 036f0678-0a87-46cf-a57a-9687a678e1d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LiteTouch
• Version Model Number: LI-FG0012A
• Catalog Number: LI-FG0012A
• Company DUNS: 514489314
• Company Name: LIGHT INSTRUMENTS LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +972-732563202
• Email: Office@light-inst.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016784015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061966

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-01-01

Devices Manufactured by LIGHT INSTRUMENTS LTD

• 07290016784008 - TIP for LITETOUCH: 2022-12-09 Package of 5 reusable tips for the LITETOUCH system
• 07290016784053 - TIP for LITETOUCH: 2022-12-09 Package of 5 reusable tips for the LITETOUCH system
• 07290016784060 - TIP for LITETOUCH: 2022-12-09 Package of 5 single-use tips for the LITETOUCH system
• 07290016784015 - LiteTouch: 2018-07-06The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety of procedures in oral
• 07290016784015 - LiteTouch: 2018-07-06 The LiteTouch is an advanced microprocessor-controlled, non-fiber all-tissue dental laser. The system is intended for a variety
• 07290016784022 - LiteTouch Applicator: 2018-07-06 YAG Laser Applicator. LiteTouch Applicator.
• 07290016784107 - E1 Handpiece, LT: 2018-07-06 Handpiece for the LightTouch system.
• 07290016784114 - Straight Handpiece, LT: 2018-07-06 Strait Hanpiece for the LightTouch system.
• 07290016784206 - TIP for LITETOUCH: 2018-07-06 Package of 5 reusable tips for the LiteTouch system.