Identity
- Trade Name
- GetHairMD FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10000-10013 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 10013 FDA UDI
- Primary DI / UDI-DI
- 00850003374161 FDA UDI
- 510(k) Number
- K173729 FDA UDI
- FDA Product Code
- OAP FDA UDI
- GMDN Term
- Hair growth laser device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Width — 20 Centimeter FDA UDIWeight — 155 Gram FDA UDILength — 22.86 Centimeter FDA UDIHeight — 15.87 Centimeter FDA UDI
Category: Hair growth laser device
GetHairMD by Revian, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hair growth laser device.
- Capillus — Capillus, LLC · Class II
- Xtrallux™ — Xtrallux, LLC · Class II
- Diode Laser Cap — Cosmo Far East Technology Limited · Class II
- Hair Boom69, Hair Boom — WONTECH CO., LTD · Class II
- HairMax — Lexington International, LLC · Class II
- RedRestore — 10589578 Canada Inc. · Class II
- Hairmax — Lexington International, LLC · Class II
- HairMax — Lexington International, LLC · Class II
Cleared under the same submission
K173729 also covers:
- 2M USB Magnetic Cable v2 Only Replacement Kit — Revian, Inc.
- REVIAN Headliner Universal Kit — Revian, Inc.
- Revian 2M USB to Magnetic Cable & Insert v2 Replacement Kit — Revian, Inc.
- Revian Inc. Replacement Kit USB-C Power Cable — Revian, Inc.
- Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug — Revian, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Revian, Inc.
Sources (1)
- FDA UDI b5d4558a-14b7-4e80-a8b2-5c4bedf4a1fe 37 fields · synced May 30, 2026