Omega Silicone, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Omega Silicone, Inc. makes
Omega Silicone, Inc. manufactures silicone-based implants and orthotic devices for facial and nasal reconstruction, including dorsal columella implants, bivalve nasal splints, septal buttons, malar implants, and chin implants.
The company’s portfolio is regulated under FDA Class I, Class II, and Unclassified (U) devices, with products listed via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Omega Dorsal Columella Implants Ref K871071
Regimes: 510(k) Registry: 510(k)Omega Bivalve Nasal Splints Ref K871073
Regimes: 510(k) Registry: 510(k)Omega Nasal Septal Button Ref K871072
Regimes: 510(k) Registry: 510(k)Omega Extended Malar And Omega Contoured Malar Ref K871074
Regimes: 510(k) Registry: 510(k)Omega Silicone Chin Implant Ref K871070
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Omega Silicone, Inc. have in the registry?
The registry currently lists 5 devices for Omega Silicone, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Omega Silicone, Inc.'s devices?
Among its 5 most recently registered devices, Omega Silicone, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Omega Silicone, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Omega Silicone, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Omega Silicone, Inc. in the registry?
The most recently registered devices listed for Omega Silicone, Inc. include OMEGA DORSAL COLUMELLA IMPLANTS, OMEGA BIVALVE NASAL SPLINTS, OMEGA NASAL SEPTAL BUTTON and OMEGA EXTENDED MALAR AND OMEGA CONTOURED MALAR.