Cleared Traditional

K171386 - dpl SpectraLite

K171386 is an FDA 510(k) clearance for dpl SpectraLite, manufactured by Led Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OHS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K171386 · Led Technologies, Inc. · General & Plastic Surgery device
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Aug 2017
Decision
88d
Days
Class 2
Risk

K171386 is an FDA 510(k) clearance for the dpl SpectraLite. Classified as Light Based Over The Counter Wrinkle Reduction (product code OHS), Class II - Special Controls.

Submitted by Led Technologies, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on August 7, 2017 after a review of 88 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 Technologies, Inc. devices

FDA 510(k) Submission Details - K171386

510(k) Number K171386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2017
Decision Date August 07, 2017
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K171386.
reVive Light Therapy LED Ultrasonic Wrinkle System
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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