revian.comRevian Lyte (10011)
Revian, Inc.
REVIAN, Inc
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015249767 | 3015249767 | REVIAN, Inc | 1 | Y | 2026-01-01 | 615 Davis Dr Ste 800 Morrisville NC US 27560 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850003374093 | Revian 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) 229-4653 | support@revian.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228332 | 1793202470 | K242441 | Revian Lyte (10011) | OAP | 2024-09-13 |
| 228332 | 1039522249 | K173729 | REVIAN RED | OAP | 2018-02-28 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OAP | 3 | 2024-09-13 |
PMN#
GUDID#
LOCKrx Red Light Cap - The LOCKrx Red Light Cap is a hair regrowth cap.
2026-05-18
GetHairMD - 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.
2025-05-07
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.
2019-03-29
REVIAN Headliner Universal Kit - The Revian Headliner Universal Kit is a replacement kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who may need a new Headliner or have lost or damaged the Headliner(s) originally supplied with the REVIAN Red Device.
2024-04-06
Revian AC Adaptor Replacement Kit - The Revian AC Adaptor Replacement Kit is a kit that may be shipped to users of the REVIAN Red device (Catalog # 10001) who have lost or misplaced their AC Adaptor originally supplied with the REVIAN Red Device
2024-04-06
Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit - The Revian 2M USB to Magnetic Cable & Insert v2 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 or Magnetic Cable originally supplied with the REVIAN Red Device.
2024-04-06
Revian 2M USB to Magnetic MicroUSB Cable Only Replacement Kit - The Revian 2M USB to Magnetic MicroUSB Cable 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 Cable originally supplied with the REVIAN Red Device.
2024-04-06
Revian 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.
2024-04-06
2M USB Magnetic Cable v2 Only Replacement Kit - 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) who have lost or misplaced their Magnetic Micro-USB Cable originally supplied with the REVIAN Red Device.
2024-08-02
Revian Inc. Replacement Kit USB-C Power Cable - 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 REVIAN Lyte device (Catalog 10011) who have lost or misplaced the power cable originally supplied with the hair regrowth device.
2024-11-19
Revian 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.
2024-11-19
Revian Lyte - The Revian Lyte is a hair regrowth cap.
2024-11-19