FDA Registration
Active
🇺🇸 United States
Sapphire
Reg #: 3012327767
·
FEI: 3012327767
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OMM IMPORTS, INC. D/B/A ZERO GRAVITY
- Registration Number
- 3012327767
- FEI Number
- 3012327767
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 940 Lincoln Rd
- City
- Miami Beach
- State
- FL
- ZIP
- 33139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172555
Owner / Operator
- Firm Name
- Omm Imports, Inc. d/b/a Zero Gravity
- Operator Number
- 10051405
- Address
- 9737 NW 41st Street, STE 234
- City
- Doral
- State
- FL
- Postal Code
- 33178
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2019-03-01 |
Proprietary Names
Sapphire
Ivory
Sapphire X
Clearist
Genesis Skye
Establishment Types
Complaint File Establishment per 21 CFR 820.198