Clarify Medical HD-01

GUDID 00865522000408

The Clarify Home Light Therapy System treats chronic dermatological diseases such as Psoriasis, Vitiligo and Eczema.

CLARIFY MEDICAL, INC.

Ultraviolet phototherapy unit, professional

• Primary Device ID: 00865522000408
• NIH Device Record Key: a4a94b85-7a67-4289-82e7-11a5203fc382
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Clarify Medical
• Version Model Number: HD-01
• Catalog Number: HD-01
• Company DUNS: 079513819
• Company Name: CLARIFY MEDICAL, 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: 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	00865522000408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170489

FDA Product Code

• FTC: Light, Ultraviolet, Dermatological

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: 2019-10-09
• Device Publish Date: 2019-10-01