FDA UDI
Not in Commercial Distribution
🇺🇸 United States
FAQ 103
DI: 07640260120051
·
Model: Blak Diamond
·
Foreo AB
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- FAQ 103
- Primary DI
- 07640260120051
- Version / Model
- Blak Diamond
- Company Name
- Foreo AB
- Labeler DUNS
- 352394143
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-18
- Public Version
- 4
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- f4796f48-6ebe-4241-b368-3907900e3e4f
- Distribution End Date
- 2024-08-07
Device Description
FAQ™ 103 devices are over-the-counter home use devices intended for facial and neck skin stimulation, and non-invasive treatments of mild to moderate facial wrinkles for adult women with all skin tones.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Neurology | 882.5890 | 2 |
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | General, Plastic Surgery | 878.4420 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45219 | Radio-frequency skin/body contouring system | An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07640260120051 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K240616 | 000 |