Qure

GUDID 08719327598719

The Q-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

Shenzhen Kaiyan Medical Equipment Co,. Ltd

Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Cosmetic red-light phototherapy system, home-use Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit Red/blue light phototherapy unit

• Primary Device ID: 08719327598719
• NIH Device Record Key: 6d0985c3-833a-4d5c-ad11-6b25871e412d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Qure
• Version Model Number: P19-0023
• 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	08719327598719 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230042

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

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

• 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
• 00850035134887 - Solawave: 2024-02-07 The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-coun
• 05060282690288 - LUSTRE: 2024-02-07 The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of