Cleared Traditional

K122248 - IGROW II HAIR GROWTH SYSTEM

K122248 is an FDA 510(k) clearance for IGROW II HAIR GROWTH SYSTEM, manufactured by Apira Science, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K122248 · Apira Science, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
131d
Days
Class 2
Risk

K122248 is an FDA 510(k) clearance for the IGROW II HAIR GROWTH SYSTEM. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Apira Science, Inc. (Chatham, US). The FDA issued a Cleared decision on December 5, 2012 after a review of 131 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 Apira Science, Inc. devices

FDA 510(k) Submission Details - K122248

510(k) Number K122248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date December 05, 2012
Days to Decision 131 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
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most General & Plastic Surgery devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01437163 Completed Interventional Industry-sponsored

Treatment of Androgenetic Alopecia in Males and Females

The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

88
Patients (actual)
4
Sites
Treatment
Purpose
Quadruple
Masking
Condition studied Androgenetic Alopecia
Study design Parallel
Eligibility All sexes · 18 Years+ · Healthy volunteers accepted
Principal investigator Raymond J. Lanzafame, MD
Sponsor Apira Science, Inc. (industry)
Started 2011-09-01 → Primary completion 2013-08-01
Primary outcome
Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - OAP Laser, Comb, Hair

All 113
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K122248.
SUNETICS CLINICAL BIO-STIMULATION LASER
K132646 · Sunetics International Marketing Group, LLC · Dec 2013
LASERBRUSH
K121920 · Sunetics International Marketing Group, LLC · Jun 2013
LASER HELMET
K122950 · Theradome, Inc. · Jun 2013
LASER HELMET
K113097 · Theradome, Inc. · Mar 2012
HAIRMAX LASERCOMB
K112524 · Lexington International, LLC · Sep 2011
HAIRMAX DUAL 12
K111714 · Lexington International, LLC · Aug 2011