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Theradome, Inc.

FDA Regulatory Profile

Theradome, Inc. has 0 FDA recalls, 1 inspection, 5 510(k) clearances and 0 compliance actions on record.

Latest inspection
Nov 20, 2017 · NAI
Latest 510(k)
May 18, 2018

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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) clearances5Oct 4, 2026Not statedCurrent
Inspections1Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Nov 20, 2017Pleasanton, CADevicesNo Action Indicated (NAI)3008295459

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
K180460Theradome LH40May 18, 2018
K171775Theradome LH80 PROJan 9, 2018
K161046Laser Helmet LH40-EVOMay 12, 2016
K122950LASER HELMETJun 14, 2013
K113097LASER HELMETMar 2, 2012

FDA data resources