Omm Imports, Inc. D/B/A Zero Gravity
United Statesfrom the FDA registration address FDA FEI 3012327767
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Perfectio LED infrared device Ref K152332
Regimes: 510(k) Registry: 510(k)Laser Hair Therapy Ref K183329
Regimes: 510(k) Registry: 510(k)Elevare, Perfectio 4 Ref K172909
Regimes: 510(k) Registry: 510(k)Sapphire, Elevare Sapphire Ref K172555
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3012327767
- Address
- 940 Lincoln Rd, Miami Beach, FL, 33139
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 1 Sep 2022 Z-1222-2023 Class II Ongoing The firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm failed to provide safety information, reproductions and locations of the labels, and a warning statement in the user manual.
Frequently asked questions
How many devices does Omm Imports, Inc. D/B/A Zero Gravity have in the registry?
The registry currently lists 4 devices for Omm Imports, Inc. D/B/A Zero Gravity. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omm Imports, Inc. D/B/A Zero Gravity's devices?
Among its 4 most recently registered devices, Omm Imports, Inc. D/B/A Zero Gravity has devices listed in FDA 510(k) (4 devices).
What risk classes do Omm Imports, Inc. D/B/A Zero Gravity's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Omm Imports, Inc. D/B/A Zero Gravity's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Omm Imports, Inc. D/B/A Zero Gravity?
FDA recall records list 1 recall initiated by Omm Imports, Inc. D/B/A Zero Gravity, the most recent initiated on 1 Sep 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Omm Imports, Inc. D/B/A Zero Gravity in the registry?
The most recently registered devices listed for Omm Imports, Inc. D/B/A Zero Gravity include Perfectio LED infrared device, Laser Hair Therapy, ELEVARE, PERFECTIO 4 and SAPPHIRE, ELEVARE SAPPHIRE.