Revian Lyte 10011

GUDID 00862712000392

The Revian Lyte is a hair regrowth cap.

Revian, Inc.

Hair growth laser device

• Primary Device ID: 00862712000392
• NIH Device Record Key: b22db712-2657-4745-8cd0-7f3e5b5e1f53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Revian Lyte
• Version Model Number: 10000-10011
• Catalog Number: 10011
• Company DUNS: 080259941
• Company Name: Revian, 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling 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	00862712000392 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242441

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: 2024-11-27
• Device Publish Date: 2024-11-19

Devices Manufactured by Revian, Inc.

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• 00850003374147 - Revian Inc. Replacement Kit USB-C Power Cable: 2024-11-27 The Revian USB-C Power Cable Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog 10001) or R
• 00862712000392 - Revian Lyte: 2024-11-27The Revian Lyte is a hair regrowth cap.
• 00862712000392 - Revian Lyte: 2024-11-27 The Revian Lyte is a hair regrowth cap.
• 00850003374116 - 2M USB Magnetic Cable v2 Only Replacement Kit: 2024-08-12 The 2M USB Magnetic Cable v2 Only Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog #10001