NURYSH

GUDID 00855950007049

A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

UPLEVITY LLC

Blue/red/infrared phototherapy lamp

• Primary Device ID: 00855950007049
• NIH Device Record Key: 5a69833c-7c97-4bd2-8e34-685f833a62c8
• Commercial Distribution Discontinuation: 2025-12-31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NURYSH
• Version Model Number: LYFT3
• Company DUNS: 099448336
• Company Name: UPLEVITY 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM
• Phone: 2036893118
• Email: THOMAS@UPLEVITY.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855950007049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180888

FDA Product Code

• OLP: Over-The-Counter Powered Light Based Laser For Acne

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: 2020-03-09
• Device Publish Date: 2020-02-28