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 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: 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

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• 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
• 05060534510524 - Omnilux Men's: 2022-11-01 Omnilux Men's Facemask Device (Red & NIR).
• 05060534510494 - Boost LED Collar: 2022-10-27 Boost LED Collar- The Light Salon