Cleared Traditional

K132800 - SKINTELL

K132800 is an FDA 510(k) clearance for SKINTELL, manufactured by Agfa Healthcare N.V.. The device is a Class 2 General & Plastic Surgery device with product code NQQ cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K132800 · Agfa Healthcare N.V. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Mar 2014
Decision
178d
Days
Class 2
Risk

K132800 is an FDA 510(k) clearance for the SKINTELL. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Agfa Healthcare N.V. (Greenville, US). The FDA issued a Cleared decision on March 3, 2014 after a review of 178 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1560 - 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 Agfa Healthcare N.V. devices

FDA 510(k) Submission Details - K132800

510(k) Number K132800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2013
Decision Date March 03, 2014
Days to Decision 178 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
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQQ Device Classification - Class 2, Special Controls

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
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 - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 24
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K132800.
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · Ninepoint Medical, Inc. · Nov 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
K182261 · Ninepoint Medical, Inc. · Oct 2018
LuminScan (TM) Imaging System
K162466 · Micro-Tech (Nanjing) Co., Ltd. · Nov 2016