Cleared Traditional

K113097 - LASER HELMET

K113097 is an FDA 510(k) clearance for LASER HELMET, manufactured by Theradome, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K113097 · Theradome, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
135d
Days
Class 2
Risk

K113097 is an FDA 510(k) clearance for the LASER HELMET. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Theradome, Inc. (Summerville, US). The FDA issued a Cleared decision on March 2, 2012 after a review of 135 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 Theradome, Inc. devices

FDA 510(k) Submission Details - K113097

510(k) Number K113097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date March 02, 2012
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
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 K113097.
LASERBRUSH
K121920 · Sunetics International Marketing Group, LLC · Jun 2013
LASER HELMET
K122950 · Theradome, Inc. · Jun 2013
IGROW II HAIR GROWTH SYSTEM
K122248 · Apira Science, Inc. · Dec 2012
HAIRMAX LASERCOMB
K112524 · Lexington International, LLC · Sep 2011
HAIRMAX DUAL 12
K111714 · Lexington International, LLC · Aug 2011
HAIRMAX LASERCOMB
K110233 · Lexington International, LLC · May 2011