Cleared Traditional

K150098 - LightStim Professional 2-Panel Light

K150098 is an FDA 510(k) clearance for LightStim Professional 2-Panel Light, manufactured by Led Intellectual Properties, LLC. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K150098 · Led Intellectual Properties, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2015
Decision
79d
Days
Class 2
Risk

K150098 is an FDA 510(k) clearance for the LightStim Professional 2-Panel Light. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Led Intellectual Properties, LLC (Irvine, US). The FDA issued a Cleared decision on April 9, 2015 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Led Intellectual Properties, LLC devices

FDA 510(k) Submission Details - K150098

510(k) Number K150098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2015
Decision Date April 09, 2015
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OHS Device Classification - Class 2, Special Controls

Product Code OHS Light Based Over The Counter Wrinkle Reduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.
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 - OHS Light Based Over The Counter Wrinkle Reduction

All 121
Devices cleared under the same product code (OHS) and FDA review panel - the closest regulatory comparables to K150098.
reVive Light Therapy LED Ultrasonic Wrinkle System
K180445 · Led Technologies, Inc. · May 2018
dpl IIa Panel
K180320 · Led Technologies, Inc. · Apr 2018
reVive Perioral
K172662 · Led Technologies, Inc. · Jan 2018
ILUMINAGE SKIN SMOOTHING LASER
K133473 · Cynosure, Inc. · Jan 2014
ILUMINAGE DIODE LASER
K111454 · Cynosure, Inc. · Jul 2012