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Led Spa

FDA Regulatory Profile

Led Spa has 0 FDA recalls, 1 inspection, 1 510(k) clearance and 0 compliance actions on record.

Latest inspection
Jan 18, 2024 · VAI
Latest 510(k)
Oct 5, 2022

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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) clearances1Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jan 18, 2024Aprilia, ItalyDevicesVoluntary Action Indicated (VAI)3006411077

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
K220138Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HPOct 5, 2022

FDA data resources