North American Kandyway Eternal Glow MD-Face 111B

GUDID 00628011719911

North American Kandyway Eternal Glow MD - Face (V2 Facemask) Legal Manufacturer- I-Smart Developments Ltd

I-SMART DEVELOPMENTS LIMITED

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

• Primary Device ID: 00628011719911
• NIH Device Record Key: 84d43f46-57bb-4409-9d51-76d8fc65513d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: North American Kandyway Eternal Glow MD-Face
• Version Model Number: TN19G
• Catalog Number: 111B
• Company DUNS: 223616320
• Company Name: I-SMART DEVELOPMENTS LIMITED
• 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	00628011719515 [Previous]
GS1	00628011719911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191629

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: 2024-05-14
• Device Publish Date: 2024-05-06

Devices Manufactured by I-SMART DEVELOPMENTS LIMITED

• 00628011719911 - North American Kandyway Eternal Glow MD-Face: 2024-05-14North American Kandyway Eternal Glow MD - Face (V2 Facemask) Legal Manufacturer- I-Smart Developments Ltd
• 00628011719911 - North American Kandyway Eternal Glow MD-Face: 2024-05-14 North American Kandyway Eternal Glow MD - Face (V2 Facemask) Legal Manufacturer- I-Smart Developments Ltd
• 05060534510838 - Dr Sabrina Eye Regenerate LED mask: 2024-05-14 Dr Sabrina Eye Regenerate LED mask- TN2189 (Wrinkle LED Eye Patch)
• 05060534510401 - EOS X by Deesse Pro: 2024-01-31 EOS X by Deesse Pro Blue, Red, Green & NIR facemask indicated for Acne and Wrinkles.
• 05060534510685 - Luma Blemish: 2023-11-03 Luma Blemish- Mini LED Patch to treat mild to moderate acne vulgaris
• 05060534510692 - Luma Revive: 2023-11-03 Luma Revive- Mini LED Patch to treat facial wrinkles
• 05060534510746 - Lightmax mini pro Eyeconic LED: 2023-11-03 Lightmax mini pro Eyeconic LED- Mini LED Patch to treat facial wrinkles
• 05060534510807 - Omnilux Blemish Eraser: 2023-11-03 Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris
• 05060534510814 - Omnilux Eye Brightener: 2023-11-03 Omnilux Eye Brightener- Mini LED Patch to treat facial wrinkles