Resonic 1004900-MDC-003

GUDID 00860006515102

Rapid Acoustic Pulse Device (RAP) is designed as an accessory to laser treatments to improve laser tattoo fading efficiency, as well as a stand alone device to improve the appearance of cellulite.

Soliton Inc

General/multiple surgical diode laser system

• Primary Device ID: 00860006515102
• NIH Device Record Key: aebd4a3d-8a0c-4cdb-afd6-c6c4df738829
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Resonic
• Version Model Number: Rapid Acoustic Pulse Device (RAP) GEN-2.2
• Catalog Number: 1004900-MDC-003
• Company DUNS: 057015198
• Company Name: Soliton Inc
• 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	00860006515102 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210964

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-11-10
• Device Publish Date: 2021-11-02