AccessGUDID - DEVICE: REVIAN RED (00862712000309)

GUDID

Device Identifier (DI) Information

Brand Name: REVIAN RED
Version or Model: 101
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10001
Company Name: Revian, Inc.

Primary DI Number: 00862712000309
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080259941 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47417	Hair growth laser device	An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OAP	Laser, Comb, Hair

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 35 Degrees Celsius
Storage Environment Humidity: less than 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Width: 20 Centimeter
Weight: 155 Gram
Length: 22.86 Centimeter
Height: 15.87 Centimeter

Device Record Status

Public Device Record Key: 26d59fb9-3f3c-40ed-a973-02f99a3a519d
Public Version Date: May 08, 2025
Public Version Number: 5
DI Record Publish Date: March 29, 2019