Lustre

GUDID 05060282690318

The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Blue/red/infrared phototherapy lamp

• Primary Device ID: 05060282690318
• NIH Device Record Key: 1aa1650f-11de-41f0-8b12-f458327e7a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lustre
• Version Model Number: PR5001
• Company DUNS: 543062382
• Company Name: Shenzhen Kaiyan Medical Equipment Co,. Ltd
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060282690318 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230720

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: 2025-07-07
• Device Publish Date: 2025-06-28

On-Brand Devices [Lustre]

• 05060282690288: The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit ener
• 05060282690325: The LUSTRE® ClearSkin REVIVE mask has two settings to allow you to create a personalised skinca
• 05060282690318: The LUSTRE 3XPREsS Light Beauty Therapy patches (Model: PR500l) is an Over-the-Counter (OTC) dev
• 05060282690301: The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001) is an Over-the-Counter (OTC) dev