Omnilux Blemish Eraser

GUDID 05060534510807

Omnilux Blemish Eraser- Mini LED Patch to treat mild to moderate acne vulgaris

I-SMART DEVELOPMENTS LIMITED

Red/blue light phototherapy unit

• Primary Device ID: 05060534510807
• NIH Device Record Key: e6b9efb8-019b-4a1c-9e55-6f2bb2203239
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnilux Blemish Eraser
• Version Model Number: TN2197
• 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	05060534510807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231555

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: 2023-11-03
• Device Publish Date: 2023-10-26

Devices Manufactured by I-SMART DEVELOPMENTS LIMITED

• 05060534510999 - C-Wave LED Mask for Neck & Décolleté: 2024-11-19 C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device)
• 05060534510951 - SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches: 2024-08-30 SMOOTHSKIN DuoLux Mini Collagen+ LED Eye Patches Mini LED Patches to treat facial wrinkles Rebrand of Luma Eye Patch (TN2189)
• 05060534510968 - SMOOTHSKIN DuoLux LED Facemask: 2024-08-30 SMOOTHSKIN DuoLux LED Facemask Rebrand of V1 Facemask (TN2010)
• 05060534510906 - Beauty Pie C-Wave Light Facial Mask: 2024-06-17 Beauty Pie C-Wave Light Facial Mask- Rebranded V1 Facemask (TN2010)
• 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