Cleared Traditional

K121326 - LANTOS 3D EAR SCANNER

K121326 is an FDA 510(k) clearance for LANTOS 3D EAR SCANNER, manufactured by Lantos Technologies. The device is a Class 1 Ear, Nose, Throat device with product code ERA cleared through the Traditional 510(k) pathway after a 268-day FDA review.

K121326 · Lantos Technologies · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
268d
Days
Class 1
Risk

K121326 is an FDA 510(k) clearance for the LANTOS 3D EAR SCANNER. Classified as Otoscope (product code ERA), Class I - General Controls.

Submitted by Lantos Technologies (South West Ranches, US). The FDA issued a Cleared decision on January 25, 2013 after a review of 268 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4770 - 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 Lantos Technologies devices

FDA 510(k) Submission Details - K121326

510(k) Number K121326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2012
Decision Date January 25, 2013
Days to Decision 268 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 90d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

ERA Device Classification - Class 1, General Controls

Product Code ERA Otoscope
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4770
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - ERA Otoscope

All 36
Devices cleared under the same product code (ERA) and FDA review panel - the closest regulatory comparables to K121326.
AIO HD OTOSCOPE
K123821 · Blue Focus · May 2013
OSRAM ITOS
K110326 · Osram Sylvania, Inc. · Oct 2011
OPTUS OTOSCOPES
K945264 · Optus, Inc. · Feb 1996
WELCH ALLYN BI-OTOSCOPE
K955043 · Welch Allyn, Inc. · Nov 1995
WELCH ALLY OTOSCOPE
K952578 · Welch Allyn, Inc. · Jul 1995
PERFECT, ENT SET, PRAKTIKANT, DE LUXE
K950913 · Rudolf Riester GmbH & Co. KG · May 1995