Cleared Special

K173843 - illumiflow 148 Laser Cap

K173843 is an FDA 510(k) clearance for illumiflow 148 Laser Cap, manufactured by Eglobal, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Special 510(k) pathway after a 39-day FDA review.

K173843 · Eglobal, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2018
Decision
39d
Days
Class 2
Risk

K173843 is an FDA 510(k) clearance for the illumiflow 148 Laser Cap. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Eglobal, LLC (Scottsdale, US). The FDA issued a Cleared decision on January 26, 2018 after a review of 39 days - a notably fast clearance cycle.

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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K173843

510(k) Number K173843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date January 26, 2018
Days to Decision 39 days
Submission Type Special
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
76d faster than avg
Panel avg: 115d · This submission: 39d
Pathway characteristics
Modification to existing cleared device.

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

Liza Burns and Associates
Liza Burns

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 115
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K173843.
Diode Laser Cap
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REVIAN RED
K173729 · Photonmd, Inc. · Feb 2018
Irradiation Aesthetic Device
K171835 · Chongqing Peninsula Medical Technology Co., Ltd. · Jan 2018
Theradome LH80 PRO
K171775 · Theradome, Inc. · Jan 2018
Hair Up
K172968 · Y & J Bio Co., Ltd. · Jan 2018
SuperGrow 272, Ultimate 272
K172982 · Super Grow Lasers · Dec 2017
K173843 · illumiflow 148 Laser Cap
Download PDF FDA Summary Eglobal, LLC