K121326 is an FDA 510(k) clearance for the LANTOS 3D EAR SCANNER. This device is classified as a Otoscope (Class I - General Controls, product code ERA).
Submitted by Lantos Technologies (South West Ranches, US). The FDA issued a Cleared decision on January 25, 2013, 268 days after receiving the submission on May 2, 2012.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4770.
| 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 |
| Product Code | ERA — Otoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 874.4770 |