Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug

Basic Information

• Brand Name: Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug
• Primary DI: 00850003374017
• Version / Model: 10000-12707
• Catalog Number: 12707
• Company Name: Revian, Inc.
• Labeler DUNS: 080259941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-19
• Public Version: 3
• Public Version Date: 2025-02-24
• Public Version Status: Update
• Public Device Record Key: daa7347e-27e7-47a8-9b59-f4360049dc8f

Device Description

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.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OAP	Laser, Comb, Hair	Physical Medicine	890.5500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850003374017	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173729	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 35 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity