Cleared Traditional

K152587 - DermaScalp Laser Cap

K152587 is an FDA 510(k) clearance for DermaScalp Laser Cap, manufactured by Dermascalp, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K152587 · Dermascalp, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
147d
Days
Class 2
Risk

K152587 is an FDA 510(k) clearance for the DermaScalp Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Dermascalp, LLC (Plano, US). The FDA issued a Cleared decision on February 4, 2016 after a review of 147 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 890.5500 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dermascalp, LLC devices

FDA 510(k) Submission Details - K152587

510(k) Number K152587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2015
Decision Date February 04, 2016
Days to Decision 147 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 115d · This submission: 147d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OAP Device Classification - Class 2, Special Controls

Product Code OAP Laser, Comb, Hair
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
Definition Promote Hair Growth In Males With Androgenic Alopecia And Norwood Hamilton Classification Of Iia To V
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - OAP Laser, Comb, Hair

All 108
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K152587.
NutraStim Hair Laser Helmet
K160728 · Nutra Luxe MD, LLC · Sep 2016
Laser Helmet LH40-EVO
K161046 · Theradome, Inc. · May 2016
Capillus272 Pro, Capillus272 OfficePro, Capillus82, Capillus202
K160285 · Capillus, LLC · Apr 2016
Capillus202
K153618 · Capillus, LLC · Jan 2016
iRestore
K151662 · Freedom Laser Therapy, Inc. · Jan 2016
HairMD
K152019 · Trophy Skin, Inc. · Nov 2015