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FDA 510(k)

LaserCap Family of Lasers 300, 224, 120 & 80

K-Number: K203826 · 2021-03-29

Decision Date2021-03-29
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LaserCap Family of Lasers 300, 224, 120 & 80 is a medical device manufactured by Transdermal Cap, Inc.. It received FDA 510(k) clearance on 2021-03-29 under approval number K203826. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LaserCap Family of Lasers 300, 224, 120 & 80?

LaserCap Family of Lasers 300, 224, 120 & 80 is a medical device that received FDA 510(k) clearance on 2021-03-29. It is manufactured by Transdermal Cap, Inc.. The 510(k) number is K203826.

When was LaserCap Family of Lasers 300, 224, 120 & 80 approved by the FDA?

LaserCap Family of Lasers 300, 224, 120 & 80 received FDA 510(k) clearance on 2021-03-29, under approval number K203826.

What company makes LaserCap Family of Lasers 300, 224, 120 & 80?

LaserCap Family of Lasers 300, 224, 120 & 80 is manufactured by Transdermal Cap, Inc..

What is the FDA product code for LaserCap Family of Lasers 300, 224, 120 & 80?

The FDA product code for LaserCap Family of Lasers 300, 224, 120 & 80 is OAP.

Other Devices by Transdermal Cap, Inc.

Related Devices (Code: OAP)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.