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Lightmed USA, Inc.

FDA Regulatory Profile

Lightmed USA, Inc. has 0 FDA recalls, 3 inspections, 2 510(k) clearances and 0 compliance actions on record.

Latest inspection
Aug 9, 2023 · NAI
Latest 510(k)
Jul 1, 2019

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances2Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Aug 9, 2023San Clemente, CADevicesNo Action Indicated (NAI)3003976404
Jun 27, 2017San Clemente, CADevicesVoluntary Action Indicated (VAI)3003976404
Jan 28, 2009San Clemente, CADevicesNo Action Indicated (NAI)3003976404

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K183173LIGHTMED Ultrasound SystemJul 1, 2019
K170761LIGHTSonic BUBMApr 13, 2018

FDA data resources