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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 a medical device manufactured by Dermascalp, LLC. It received FDA 510(k) clearance on 2016-02-04 under approval 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. It is manufactured by Dermascalp, LLC. The 510(k) number is K152587.

When was DermaScalp Laser Cap approved by the FDA?

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

What company makes DermaScalp Laser Cap?

DermaScalp Laser Cap is manufactured by Dermascalp, LLC.

What is the FDA product code for DermaScalp Laser Cap?

The FDA product code for DermaScalp Laser Cap is OAP.

Other Devices by Dermascalp, LLC

K173846DermaScalp Laser Cap

Related Devices (Code: OAP)

K162994Capillus302, Capillus312, Capillus352Capillus, LLC K161875LaserCap300, LaserCap224, LaserCap120, LaserCap80Transdermal Cap, Inc. K160728NutraStim Hair Laser HelmetNutra Luxe MD, LLC K161046Laser Helmet LH40-EVOTheradome, Inc. K160285Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202Capillus, LLC K153618Capillus202Capillus, LLC

Official Source

View on FDA Database →

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

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