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Lelo, Inc.

FDA Regulatory Profile

Lelo, Inc. appears in FDA public data with 0 recalls, 3 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on March 7, 2025.

Summary

Total Recalls
0
510(k) Clearances
3
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243421Lelo Hex Lubricated Natural Rubber Latex CondomMarch 7, 2025
K162511LELO RESPECT HEX Natural Rubber Latex CondomJanuary 13, 2017
K160644Lelo Hex Natural Rubber Latex CondomJune 30, 2016

FDA data resources