Orbital LED Mask

GUDID 00858830007061

LED light for the treatment of wrinkles

PULSADERM LLC

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp

• Primary Device ID: 00858830007061
• NIH Device Record Key: 739c5ca4-6552-4545-a9fb-412dddfe627e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orbital LED Mask
• Version Model Number: RB2015
• Company DUNS: 080429881
• Company Name: PULSADERM LLC
• 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: false
• Manufacturing Date: false
• 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	00858830007061 [Primary]

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: 2018-11-05
• Device Publish Date: 2018-10-04

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• 00858830007061 - Orbital LED Mask: 2018-11-05 LED light for the treatment of wrinkles
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• 00864918000312 - Pulsaderm RED LED Skin Renewal: 2018-11-05 Red LED Light for Wrinkles
• 00864918000329 - Blue LED Acne Clearing Light: 2018-11-05 Blue LED Light for the treatment of mild to moderate acne