FDA Registration
Active
🇺🇸 United States
OMM IMPORTS, INC. D/B/A ZERO GRAVITY
Reg #: 3012327767
·
FEI: 3012327767
·
Expires 2026
Products
4
Proprietary Names
26
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OMM IMPORTS, INC. D/B/A ZERO GRAVITY
- Registration Number
- 3012327767
- FEI Number
- 3012327767
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 940 Lincoln Rd
- City
- Miami Beach
- State
- FL
- ZIP
- 33139
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152332
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 |
|---|---|---|---|---|---|
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2019-03-01 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2019-10-22 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2019-03-01 |
| Laser, Comb, Hair | OAP | Class 2 | Physical Medicine | No | 2019-03-25 |
Proprietary Names
Perfectio
Juvenis
Perfectio Plus Special Edition
Perfectio Plus
MODEL S+ BY SPIRULUX
Relaxatio
Perfectio X
RED
Spirulux Model S
ONE by ELEVARE
PRO MED BY JOUVALLE
Ivory
Sapphire
Sapphire X
Genesis Skye
Clearist
Recreo
Revv
Elevare Plus
Elevare Limited
Genesis Z
Glorifico
Glorifico Plus
Perfectio X G2
Rejuvenist
Quantum
Establishment Types
Complaint File Establishment per 21 CFR 820.198