Cleared Traditional

K173678 - Diode Laser Cap

K173678 is an FDA 510(k) clearance for Diode Laser Cap, manufactured by Cosmo Far East Technology Limited. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K173678 · Cosmo Far East Technology Limited · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2018
Decision
90d
Days
Class 2
Risk

K173678 is an FDA 510(k) clearance for the Diode Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Cosmo Far East Technology Limited (Shenzhen, CN). The FDA issued a Cleared decision on February 28, 2018 after a review of 90 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 Cosmo Far East Technology Limited devices

FDA 510(k) Submission Details - K173678

510(k) Number K173678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2017
Decision Date February 28, 2018
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 Consultant

Feiying Drug & Medical Consulting Technical Service Group
Rain Yip

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OAP Laser, Comb, Hair

All 71
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K173678.
Hair Up
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Theradome LH40
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DermaScalp Laser Cap
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REVIAN RED
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illumiflow 148 Laser Cap
K173843 · Eglobal, LLC · Jan 2018