South West Intl., Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What South West Intl., Inc. makes
South West Intl., Inc. manufactures optical devices, including the SIOM, SOLEX, SAXON INT’L OPTICAL OF HONG KONG, MASUNAGA OPTICAL MANUFACTURING, and KOELN OPTIK products. These items are designed for ophthalmic use, such as lenses, frames, or related optical components.
The company’s portfolio consists of Class I medical devices, which are generally low-risk and subject to 510(k) clearance through the FDA. These products are listed under the U.S. regulatory framework, adhering to applicable Class I requirements.
Catalogue
Siom Ref K854343
Regimes: 510(k) Registry: 510(k)Solex & Saxon Int'l Optical Of Hong Kong Ref K851661
Regimes: 510(k) Registry: 510(k)Masunaga Optical Manufacturing Ref K862502
Regimes: 510(k) Registry: 510(k)Koeln Optik Ref K862503
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does South West Intl., Inc. have in the registry?
The registry currently lists 4 devices for South West Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list South West Intl., Inc.'s devices?
Among its 4 most recently registered devices, South West Intl., Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do South West Intl., Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for South West Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from South West Intl., Inc. in the registry?
The most recently registered devices listed for South West Intl., Inc. include SIOM, SOLEX & SAXON INT'L OPTICAL OF HONG KONG, MASUNAGA OPTICAL MANUFACTURING and KOELN OPTIK.