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Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug
FDA UDIClass II (US FDA UDI)
by Revian, Inc.
Identity
- Trade Name
- Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10000-12707 FDA UDI
- 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. FDA UDI
Identifiers
- Catalog Number
- 12707 FDA UDI
- Primary DI / UDI-DI
- 00850003374017 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hair growth laser device
Revian Inc. Replacement Kit, 120V AC-5V DC, 2A Wall, Type A Plug by Revian, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hair growth laser device.
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- 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
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 |
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Manufacturer
- Manufacturer
- Revian, Inc.
Sources (1)
- FDA UDI daa7347e-27e7-47a8-9b59-f4360049dc8f 37 fields · synced Jun 8, 2026