# K121326: Lantos 3D Ear Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Lantos Technologies
- Decided: Jan 25, 2013 after 268 days
- Product code: ERA (Otoscope)
- Device class: 1
- Regulation: 21 CFR 874.4770
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943916 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943916: Videotoscope, Welch Allyn, Inc. (1994) Summary page 1.

## Indications for use
The Lantos 3D Ear Scanner is intended for use by a trained hearing professional on patients 18 years of age and older presenting for inspection of the external ear canal. The Lantos 3D Ear scanner: * provides a magnified visual image for inspection of the external ear canal and tympanic membrane, and provides illumination of the ear canal for inspection and; * includes an expanding membrane that can be inserted and conforms to the external ear canal when filled with an absorbing medium which enables the 3D scan and; * records and presents to the hearing professional in an image file a topology measurement of the external ear canal

Source page: https://510kreport.com/device/K121326
Methodology: https://510kreport.com/methodology