LUSTRE

GUDID 05060282690288

The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use

• Primary Device ID: 05060282690288
• NIH Device Record Key: b1a814ea-0ec9-43cd-912c-d8277d0ed65e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LUSTRE
• Version Model Number: PR4001
• 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: true
• Serial Number: true
• Manufacturing Date: true
• 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	05060282690288 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230124

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction
• 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: 2024-02-07
• Device Publish Date: 2024-01-30

Devices Manufactured by Shenzhen Kaiyan Medical Equipment Co,. Ltd

• 00655729008235 - CurrentBody Skin™: 2024-10-21 The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-f
• 06970006971649 - Lumaflex: 2024-09-10 The Lumaflex Panel (Model: ZLD-05A) is intended to deliver heat in the red and infrared spectrum to provide topical heating for
• 09331923700472 - Ellodi: 2024-02-09 The LED Light Therapy Mask (Models: EL00003) is an over the counter device intended to emit energy in the red and blue region of
• 00794712393542 - DR.NAOMI: 2024-02-08 The LED Light Therapy Mask (Models: MK-78)is an over the counter device that is intended for the use in the treatment of full-fa
• 00655729008266 - CurrentBody Skin™: 2024-02-07 The LED Eye Perfector (Model: EY-36A) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the perio
• 00655729008426 - CurrentBody Skin™: 2024-02-07 The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase
• 00731093153136 - CurrentBody Skin™: 2024-02-07 The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in male
• 00850035134368 - Solawave: 2024-02-07 The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-cou