GetHairMD 10013

GUDID 00850003374161

This is a private label device. The device is Revian's design P/N 10000-10001 (K173729) with modified GetHairMD logos and colors for private labeling. There are no other differences between the products.

Revian, Inc.

Hair growth laser device

• Primary Device ID: 00850003374161
• NIH Device Record Key: b5d4558a-14b7-4e80-a8b2-5c4bedf4a1fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GetHairMD
• Version Model Number: 10000-10013
• Catalog Number: 10013
• 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

Device Dimensions

• 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 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	00850003374161 [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: 2025-05-15
• Device Publish Date: 2025-05-07

Devices Manufactured by Revian, Inc.

• 00850003374161 - GetHairMD: 2025-05-15This is a private label device. The device is Revian's design P/N 10000-10001 (K173729) with modified GetHairMD logos and colors for private labeling. There are no other differences between the products.
• 00850003374161 - GetHairMD: 2025-05-15 This is a private label device. The device is Revian's design P/N 10000-10001 (K173729) with modified GetHairMD logos and colors
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