FDA Registration
Active
🇺🇸 United States
REMY Therapy Laser System
Reg #: 3015529593
·
FEI: 3015529593
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- FootDocPreneur, LLC
- Registration Number
- 3015529593
- FEI Number
- 3015529593
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 1803 Country Club Drive
- City
- Cherry Hill
- State
- NJ
- ZIP
- 08003
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190034
Owner / Operator
- Firm Name
- Footdocprenur, LLC
- Operator Number
- 10060366
- Address
- 1803 Country Club Drive
- City
- Cherry Hill
- State
- NJ
- Postal Code
- 08003
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2019-05-16 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2019-05-16 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2019-05-16 |
Proprietary Names
REMY Therapy Laser System
ATLAS Therapy Laser System
Establishment Types
Complaint File Establishment per 21 CFR 820.198