InPulse Dental Laser

GUDID 00860367000309

INCISIVE, LLC

Dental solid-state laser system

• Primary Device ID: 00860367000309
• NIH Device Record Key: 133a557e-3e79-4cb8-93c1-25df0ab72796
• Commercial Distribution Discontinuation: 2020-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InPulse Dental Laser
• Version Model Number: InPulse Touch 120
• Company DUNS: 009493060
• Company Name: INCISIVE, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com
• Phone: 510-669-9401
• Email: myessik@gmail.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860367000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131805

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

[00860367000309]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-20

Devices Manufactured by INCISIVE, LLC

• 00860367000309 - InPulse Dental Laser: 2018-07-06
• 00860367000309 - InPulse Dental Laser: 2018-07-06
• 00860367000316 - InPulse Dental Laser: 2018-03-29 Fiberoptic delivery cable