FDA.reportPublic FDA data

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
00850003374093Revian Magnetic Micro-USB Connector Only Replacement Kit - The Revian Magnetic Micro-USB Connector Only Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their Magnetic Micro-USB Connector originally supplied with the REVIAN Red 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