REVIAN RED 10001

GUDID 00862712000309

REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment.REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.

PHOTONMD, INC.

Hair growth laser device

• Primary Device ID: 00862712000309
• NIH Device Record Key: 26d59fb9-3f3c-40ed-a973-02f99a3a519d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REVIAN RED
• Version Model Number: 101
• Catalog Number: 10001
• Company DUNS: 080259941
• Company Name: PHOTONMD, INC.
• 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: false
• 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

Customer Support Contacts

• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com
• Phone: (919) 229-4653
• Email: support@revian.com

Device Dimensions

• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter
• Width: 20 Centimeter
• Weight: 155 Gram
• Length: 22.86 Centimeter
• Height: 15.87 Centimeter

Operating and Storage Conditions

• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862712000309 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173729

FDA Product Code

• OAP: Laser, Comb, Hair

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: 2019-04-08
• Device Publish Date: 2019-03-29

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• 00862712000378 - REVIAN Headliner Universal Kit: 2024-04-15 The Revian Headliner Universal Kit is a replacement kit that may be shipped to users of the REVIAN Red device (Catalog # 10001)
• 00862712000309 - REVIAN RED: 2019-04-08REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated via a mobile application to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment.REVIAN RED is a system comprised of a wearable soft textile Cap using driver electronics,a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board. REVIAN RED is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled via a wireless Bluetooth connection to a mobile application operating on a wireless device.
• 00862712000309 - REVIAN RED: 2019-04-08 REVIAN RED is a non-invasive, hands-free device indicated to treat androgenetic alopecia in both men and women. It is operated v