Revian Red

FDA UDI

Class II (US FDA UDI)

by Revian, Inc.

Identity

Trade Name: REVIAN RED FDA UDI
Generic Name: Hair growth laser device FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 101 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: 10001 FDA UDI
Primary DI / UDI-DI: 00862712000309 FDA UDI
FDA Product Code: OAP FDA UDI
GMDN Term: Hair growth laser device FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 890.5500 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Width — 20 Centimeter FDA UDI
Weight — 155 Gram FDA UDI
Length — 22.86 Centimeter FDA UDI
Height — 15.87 Centimeter FDA UDI

Category: Hair growth laser device

Revian Red by Revian, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hair growth laser device.

Capillus — Capillus, LLC · Class II
Xtrallux™ — Xtrallux, LLC · Class II
Diode Laser Cap — Cosmo Far East Technology Limited · Class II
Hair Boom69, Hair Boom — WONTECH CO., LTD · Class II
HairMax — Lexington International, LLC · Class II
RedRestore — 10589578 Canada Inc. · Class II
Hairmax — Lexington International, LLC · Class II
HairMax — Lexington International, LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Revian, Inc.

Sources (1)

FDA UDI 26d59fb9-3f3c-40ed-a973-02f99a3a519d 37 fields · synced May 30, 2026