FDA.reportPublic FDA data

REVIAN, Inc

Matched from indexed company URL: Revian, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30152497673015249767REVIAN, Inc1Y2026-01-01615 Davis Dr Ste 800 Morrisville NC US 27560

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00850003374017Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug - Power adapter replacement kit. The Revian 120V AC-5V DC power adapter replacement kit is a kit that may be shipped to users of the REVIAN Red device (Catalog 10001) or REVIAN Lyte device (Catalog 10011) who have lost or misplaced their AC adapter originally supplied with the hair restoration device.919-229-4653support@revian.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2283321793202470K242441Revian Lyte (10011)OAP2024-09-13
2283321039522249K173729REVIAN REDOAP2018-02-28

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OAP32024-09-13

PMN#

GUDID#

REVIAN RED - 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.

Revian, Inc.

2019-03-29