510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121326Substantially Equivalent

Lantos 3D Ear Scanner

Lantos Technologies, South West Ranches FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121326 is the FDA 510(k) clearance record for LANTOS 3D EAR SCANNER, a class I device, cleared for Lantos Technologies on under FDA product code ERA (Otoscope). FDA records list one 510(k) clearance for Lantos Technologies. As of , FDA records show no recalls naming K121326.

Clearance record

Decision date
Received
(268 days to decision)
Product code
ERA Otoscope
Regulation
21 CFR 874.4770
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Lantos Technologies 20310 SW 48th St., South West Ranches FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ERA

Trailing 12 months

FDA records hold no clearances under product code ERA in the trailing twelve months.

FDA records show no clearances under product code ERA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ERA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260