Cleared Traditional

K191804 - TOMi Scope (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191804 · Photonicare, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
153d
Days
Class 2
Risk

K191804 is an FDA 510(k) clearance for the TOMi Scope. Classified as Device System, Imaging, Tympanic Membrane And Middle Ear (product code QJG), Class II - Special Controls.

Submitted by Photonicare, Inc. (Champaign, US). The FDA issued a Cleared decision on December 5, 2019 after a review of 153 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 892.1560 - the FDA ear, nose and throat 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Photonicare, Inc. devices

Submission Details

510(k) Number K191804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2019
Decision Date December 05, 2019
Days to Decision 153 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 89d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QJG Device System, Imaging, Tympanic Membrane And Middle Ear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition Is Intended For Use As An Imaging Tool For Visualization Of The Human Tympanic Membrane And Middle Ear Space.
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 Ear, Nose, Throat devices follow this clearance model.