Identity
- Trade Name
- FAQ 101 FDA UDI
- Generic Name
- Multi-modality skin/body contouring system FDA UDI
- Device Name
- FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI. FDA UDI
- Model / Reference
- Amethyst FDA UDI
- Description
- FAQ™ 101 device is an over-the-counter home use devices intended for non-invasive treatments of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-VI. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640260120037 FDA UDI
- 510(k) Number
- K222012 FDA UDI
- FDA Product Code
- PAY FDA UDIOHS FDA UDI
- GMDN Term
- Multi-modality skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4420 FDA UDI878.4810 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
Category: Multi-modality skin/body contouring system
Faq 101 by Foreo Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Foreo Inc
Sources (1)
- FDA UDI 1f6b005c-018b-44de-92ac-a9d918502791 34 fields · synced May 30, 2026