Cleared Traditional

K162071 - IllumiFlow Laser Cap

K162071 is an FDA 510(k) clearance for IllumiFlow Laser Cap, manufactured by Eglobal, LLC. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K162071 · Eglobal, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
212d
Days
Class 2
Risk

K162071 is an FDA 510(k) clearance for the IllumiFlow 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 February 24, 2017 after a review of 212 days - an extended review 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. 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 Eglobal, LLC devices

FDA 510(k) Submission Details - K162071

510(k) Number K162071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2016
Decision Date February 24, 2017
Days to Decision 212 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
97d slower than avg
Panel avg: 115d · This submission: 212d
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

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 108
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K162071.
SuperGrow 272, Ultimate 272
K172982 · Super Grow Lasers · Dec 2017
Grivamax Hair Growth System
K171895 · Leana Orders, Inc. · Aug 2017
iHelmet Hair Growth System
K162782 · Slinph Technologies Co., Ltd. · Apr 2017
Capillus 82, Capillus 202, Capillus 272 Pro, 272 Office Pro, Capillus 302, Capillus 312, and Capillus 352
K163170 · Capillus, LLC · Jan 2017
Capillus302, Capillus312, Capillus352
K162994 · Capillus, LLC · Nov 2016
LaserCap300, LaserCap224, LaserCap120, LaserCap80
K161875 · Transdermal Cap, Inc. · Sep 2016