Medical Device Manufacturer · US , San Jose , CA

Lelo, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2016

3

Total

3

Cleared

0

Denied

FDA 510(k) cleared devices by Lelo, Inc. Obstetrics & Gynecology ✕

3 devices

1-3 of 3

Cleared Mar 07, 2025

Lelo Hex Lubricated Natural Rubber Latex Condom

Obstetrics & Gynecology · 123d

Cleared Jan 13, 2017

LELO RESPECT HEX Natural Rubber Latex Condom

Obstetrics & Gynecology · 127d

Cleared Jun 30, 2016

Lelo Hex Natural Rubber Latex Condom

Obstetrics & Gynecology · 115d