Lelo, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Lelo, Inc. makes
Lelo, Inc. manufactures natural rubber latex condoms, including plain, lubricated, and textured variants designed for barrier contraception and sexually transmitted infection prevention. The portfolio includes single-use condoms with and without added lubrication, marketed under specific product names like 'Hex' and 'RESPECT HEX'.
These products are classified as Class II medical devices under US regulations and are authorised via the FDA’s 510(k) pathway. The company is based in the United States, and its devices are listed in the FDA’s 510(k) registry.
Catalogue
Lelo Hex Natural Rubber Latex Condom Ref K160644
Regimes: 510(k) Registry: 510(k)LELO RESPECT HEX Natural Rubber Latex Condom Ref K162511
Regimes: 510(k) Registry: 510(k)Lelo Hex Lubricated Natural Rubber Latex Condom Ref K243421
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Lelo, Inc. have in the registry?
The registry currently lists 3 devices for Lelo, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Lelo, Inc.'s devices?
Among its 3 most recently registered devices, Lelo, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Lelo, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Lelo, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Lelo, Inc. in the registry?
The most recently registered devices listed for Lelo, Inc. include Lelo Hex Natural Rubber Latex Condom, LELO RESPECT HEX Natural Rubber Latex Condom and Lelo Hex Lubricated Natural Rubber Latex Condom.