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510(k) K121326

LANTOS 3D EAR SCANNER by Lantos Technologies — Product Code ERA

K121326 is an FDA 510(k) premarket notification submitted by Lantos Technologies for the device "LANTOS 3D EAR SCANNER". The FDA issued a decision of Substantially Equivalent on January 25, 2013. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2013
Date Received
May 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951255 — IMEDGE VIDEO OSTOSCOPE (ANALOG) (April 13, 1995)

FDA data resources