FDA Registration
Active
🇺🇸 United States
FOREO INC
Reg #: 3012104022
·
FEI: 3012104022
·
Expires 2026
Products
10
Proprietary Names
49
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- FOREO INC
- Registration Number
- 3012104022
- FEI Number
- 3012104022
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1525 E Pama Lane
- City
- Las Vegas
- State
- NV
- ZIP
- 89119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K222012
Owner / Operator
- Firm Name
- FOREO INC
- Operator Number
- 10050498
- Address
- 1525 E Pama Lane
- City
- Las Vegas
- State
- NV
- Postal Code
- 89119
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Toothbrush, Powered | JEQ | Class 1 | Dental | No | 2015-11-24 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-07-25 |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | Class 2 | General, Plastic Surgery | No | 2023-07-25 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2023-11-30 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2026-02-25 |
| Heat Source For Bleaching Teeth | EEG | Class 1 | Dental | No | 2026-04-28 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2024-05-14 |
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2024-12-16 |
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2023-10-26 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-10-26 |
Proprietary Names
ISSA MINI SET
ISSA 4 BABY
ISSA MINI 2 SENSITIVE
ISSA PLAY
ISSA SENSTIVE
ISSA 4
ISSA Hybrid Wave Brush Head Lavender
ISSA MIKRO
ISSA 4 PLUS
ISSA baby Brush Head Pearl Pink
ISSA PRO SET
ISSA 3
ISSA COMPACT
ISSA 2 SENSITIVE SET
ISSA BABY
ISSA 2
ISSA HYBRID BRUSH HEAD
ISSA BRUSH HEAD
ISSA baby Brush Head Bubble Blue
ISSA KIDS SENSITIVE
ISSA KIDS
ISSA MINI
ISSA HYBRID
ISSA baby Brush Head Kiwi Green
ISSA MINI 3
ISSA 4 SMILE
FAQ 101
KIWI derma
FAQ LED Panel
ISSA Teeth Whitening Device
BEAR 2 Body
FAQ 302
ESPADA 2
ESPADA 2 PLUS
BEAR MINI
BEAR
Bear 2 eyes & lips
Bear 2
Bear 2 go
PEACH 2 Duo
PEACH 2 Pro Max
PEACH 2 go
PEACH 2
FAQ 201
FAQ 202 Plus
FAQ 202
FAQ 103
FAQ 102
Luna 4 Plus
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device