LaserTouchOne

GUDID 00869340000305

RENEWAL TECHNOLOGIES LLC

Musculoskeletal/physical therapy laser, home-use

• Primary Device ID: 00869340000305
• NIH Device Record Key: 66ea8976-f214-4063-9f4f-bace5e70cd5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LaserTouchOne
• Version Model Number: 1
• Company DUNS: 078372848
• Company Name: RENEWAL TECHNOLOGIES LLC
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869340000305 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100116

FDA Product Code

• NHN: Powered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-08
• Device Publish Date: 2017-05-11