Cleared Traditional

K160240 - Perimeter Otis™ 1.0 Optical Coherence Tomography System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K160240 · Perimeter Medical Imaging, Inc. · General & Plastic Surgery device
May 2016
Decision
102d
Days
Class 2
Risk

K160240 is an FDA 510(k) clearance for the Perimeter Otis™ 1.0 Optical Coherence Tomography System. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Perimeter Medical Imaging, Inc. (Toronto, CA). The FDA issued a Cleared decision on May 13, 2016 after a review of 102 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K160240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 01, 2016
Decision Date May 13, 2016
Days to Decision 102 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 132d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 9
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K160240.
LIA Console (542-7)
K251730 · Leadoptik, Inc. · Dec 2025
HyperVue™ Imaging System - Integrated
K253101 · Spectrawave, Inc. · Dec 2025
deepLive (OSP12 + DMS)
K252851 · Damae Medical · Oct 2025
HyperVue™ Software
K251198 · Spectrawave, Inc. · Jul 2025
OPUSWAVE Dual Sensor Imaging System
K250684 · Terumo Cardiovascular Systems Thi Plant · Jul 2025
OPXION Optical Skin Viewer (OPXSV1-01F)
K242924 · Opxion Technology, Inc. · Jun 2025