Transdermal Cap, Inc.

FDA Regulatory Profile

Transdermal Cap, Inc. has 0 FDA recalls, 5 inspections, 3 510(k) clearances and 1 compliance action on record.

Latest inspection
Jun 6, 2025 · VAI
Latest 510(k)
Mar 29, 2021

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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) clearances3Oct 4, 2026Not statedCurrent
Inspections5Oct 26, 2026Not statedCurrent
Compliance actions1Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 6, 2025Highland Heights, OHDevicesVoluntary Action Indicated (VAI)3008699663
Mar 26, 2024Highland Heights, OHDevicesVoluntary Action Indicated (VAI)3008699663
Sep 22, 2016Highland Heights, OHDevicesVoluntary Action Indicated (VAI)3008699663
Jun 30, 2015Highland Heights, OHDevicesOfficial Action Indicated (OAI)3008699663
May 29, 2013Highland Heights, OHDevicesVoluntary Action Indicated (VAI)3008699663

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
K203826LaserCap Family of Lasers 300, 224, 120 & 80Mar 29, 2021
K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Sep 30, 2016
K150613LaserCap LC Pro and LC EliteJul 22, 2015