Identity
- Trade Name
- Revian AC Adaptor Replacement Kit FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 10000-12400 FDA UDI
- Description
- 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 FDA UDI
Identifiers
- Catalog Number
- 12400 FDA UDI
- Primary DI / UDI-DI
- 00862712000316 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
- Not 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
Revian AC Adaptor Replacement Kit by Revian, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K173729 also covers:
- 2M USB Magnetic Cable v2 Only Replacement Kit — Revian, Inc.
- GetHairMD — 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 |
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Manufacturer
- Manufacturer
- Revian, Inc.
Sources (1)
- FDA UDI 6500c75b-8fe7-4350-b780-735a7226286a 38 fields · synced May 31, 2026