Omnilux CLEAR 135-OC

GUDID 05060534510234

Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded

I-SMART DEVELOPMENTS LIMITED

Red/blue light phototherapy unit

• Primary Device ID: 05060534510234
• NIH Device Record Key: 48a154a0-b93d-416c-bc38-b09e1a0a14bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omnilux CLEAR
• Version Model Number: TN2112
• Catalog Number: 135-OC
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -5 Degrees Celsius and 55 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060534510234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210948

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: 2021-07-13
• Device Publish Date: 2021-07-05

Devices Manufactured by I-SMART DEVELOPMENTS LIMITED

• 05060534511156 - The Dynamo Deep LED Collagen-Boosting Mask: 2025-08-29 The Dynamo Deep LED Collagen-Boosting Mask is a rebrand of Luma Pro Face- TN2332. Facemask indicated for the treatment of full f
• 05060534511163 - Light therapy LED facemask from City Beauty: 2025-08-25 Light therapy LED facemask from City Beauty rebrand of V1 facemask (TN2010)
• 05060534510982 - Dp DERMACEUTICALS L.E.D.+ FACE: 2025-04-15 Dp DERMACEUTICALS L.E.D.+ FACE is a rebrand of Luma Pro Face- TN2332. Facemask indicated for the treatment of full facial wrinkl
• 05060534511064 - UKSKIN LED Dual Light Pro-Therapy Face Mask: 2025-02-10 UKSKIN LED Dual Light Pro-Therapy Face Mask rebrand of V1 facemask (TN2010)
• 05060534510944 - Glo Mask: 2025-02-04 Glo Mask Rebrand of Luma Pro Facemask (TN2332)- Indicated for Wrinkles.
• 05060534511002 - QMS Derma Expert Facemask: 2025-02-04 QMS Derma Expert Facemask Rebrand of Luma Pro Face- TN2332. Facemask indicated for the treatment of full facial wrinkles
• 05060534511071 - Beauty Pie C -WAVE REJUVENATING LED TREATMENT FOR HANDS: 2025-01-30 Beauty Pie C -WAVE REJUVENATING LED TREATMENT FOR HANDS Brand Variant of the LED Glove (TN19S)
• 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)