Cleared Traditional

K151662 - iRestore

K151662 is an FDA 510(k) clearance for iRestore, manufactured by Freedom Laser Therapy, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OAP cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K151662 · Freedom Laser Therapy, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
201d
Days
Class 2
Risk

K151662 is an FDA 510(k) clearance for the iRestore. Classified as Laser, Comb, Hair (product code OAP), Class II - Special Controls.

Submitted by Freedom Laser Therapy, Inc. (Los Angeles, US). The FDA issued a Cleared decision on January 6, 2016 after a review of 201 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 Freedom Laser Therapy, Inc. devices

FDA 510(k) Submission Details - K151662

510(k) Number K151662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2015
Decision Date January 06, 2016
Days to Decision 201 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
86d slower than avg
Panel avg: 115d · This submission: 201d
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

Nst Consulting, LLC
Raymond R. Blanche

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 113
Devices cleared under the same product code (OAP) and FDA review panel - the closest regulatory comparables to K151662.
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HairMD
K152019 · Trophy Skin, Inc. · Nov 2015
Capillus82
K151516 · Capillus, LLC · Aug 2015
LaserCap LC Pro and LC Elite
K150613 · Transdermal Cap, Inc. · Jul 2015