Iluminage HU-CO00621

GUDID 10806248006333

Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital and perioral wrinkles.

Tanda Beauty Canada, Inc

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 10806248006333
• NIH Device Record Key: e04a2ddf-892c-471b-ab8b-d2b64aace65a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Iluminage
• Version Model Number: HU-CO00621
• Catalog Number: HU-CO00621
• Company DUNS: 248047115
• Company Name: Tanda Beauty Canada, 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: true
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00806248006336 [Primary]
GS1	10806248006333 [Package]; Contains: 00806248006336; Package: Master Carton [1 Units]; In Commercial Distribution

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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: 2020-02-24
• Device Publish Date: 2016-10-19

On-Brand Devices [Iluminage]

• 00806248007296: Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital an
• 10806248006333: Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital an
• 10806248005329: Battery powered, home use (OTC) diode laser indicated for use in the treatment of periorbital an