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) Regulatory Record - Lelo, Inc. Obstetrics & Gynecology ✕
3 devices
1-3 of 3
Cleared Mar 07, 2025
Lelo Hex Lubricated Natural Rubber Latex Condom
K243421 · HIS
Obstetrics & Gynecology · 123d
Cleared Jan 13, 2017
LELO RESPECT HEX Natural Rubber Latex Condom
K162511 · HIS
Obstetrics & Gynecology · 127d
Cleared Jun 30, 2016
Lelo Hex Natural Rubber Latex Condom
K160644 · HIS
Obstetrics & Gynecology · 115d
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