FDA Registration
Active
🇺🇸 United States
OTZ Partners, LLC
Reg #: 3015529593
·
FEI: 3015529593
·
Expires 2026
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- OTZ Partners, LLC
- Registration Number
- 3015529593
- FEI Number
- 3015529593
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 5755 N Point Pkwy Ste 12
- City
- Alpharetta
- State
- GA
- ZIP
- 30022
- Country
- US
Regulatory Submissions
- 510(k) Number
- K190034
Owner / Operator
- Firm Name
- OTZ Partners LLC dba Remy Laser, LLC
- Operator Number
- 10094566
- Address
- 5755 North Point Parkway, Suite 12
- City
- Alpharetta
- State
- GA
- Postal Code
- 30022
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2026-03-10 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2025-12-08 |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | Class 2 | General, Plastic Surgery | No | 2025-12-08 |
Proprietary Names
REMY Fx Quad Wave Medical Diode Laser System
REMY Dual Wave Medical Diode Laser System
REMY Single Wave Medical Diode Laser System
Establishment Types
Complaint File Establishment per 21 CFR 820.198