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FDA 510(k)

DermaScalp Laser Cap

K-Number: K152587 · 2016-02-04

ApplicantDermascalp, LLC
Decision Date2016-02-04
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DermaScalp Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Dermascalp, LLC. It received FDA 510(k) clearance on 2016-02-04 under 510(k) number K152587. 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 DermaScalp Laser Cap?

DermaScalp Laser Cap is a medical device that received FDA 510(k) clearance on 2016-02-04. The listed applicant is Dermascalp, LLC. The 510(k) number is K152587.

When did DermaScalp Laser Cap receive FDA 510(k) clearance?

DermaScalp Laser Cap received FDA 510(k) clearance on 2016-02-04, under 510(k) number K152587.

Who is the listed applicant for DermaScalp Laser Cap?

The FDA 510(k) record lists Dermascalp, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DermaScalp Laser Cap?

The FDA product code for DermaScalp Laser Cap is OAP.

Other records listing Dermascalp, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K173846DermaScalp Laser Cap

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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