UltraSmooth Digital 60009

GUDID 00860925000345

UltraSmooth Digital, Green Light (532nm)

WARD PHOTONICS LLC

Low-intensity laser fat liquefaction system

• Primary Device ID: 00860925000345
• NIH Device Record Key: 0b93a7d1-1924-4150-9303-4917a6c92ec5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraSmooth Digital
• Version Model Number: 60009
• Catalog Number: 60009
• Company DUNS: 090686710
• Company Name: WARD PHOTONICS 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860925000345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202361

FDA Product Code

• OLI: Fat Reducing Low Level Laser

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: 2021-01-12
• Device Publish Date: 2021-01-04

Devices Manufactured by WARD PHOTONICS LLC

• 00860925000338 - UltraSlim Digital: 2021-01-12 UltraSlim Digital, Red Light (635nm)
• 00860925000345 - UltraSmooth Digital: 2021-01-12UltraSmooth Digital, Green Light (532nm)
• 00860925000345 - UltraSmooth Digital: 2021-01-12 UltraSmooth Digital, Green Light (532nm)
• 00860925000314 - Cellulize: 2020-01-27 Cellulize, Green Light (532nm)
• 00860925000307 - Photonica Professional: 2020-01-20 Photonica Professional, Red Light (635 nm)
• 00086092500307 - Photonica Professional: 2018-03-29 Photonica Professional, Red Light (635 nm)