510(k) K173920

LS OIL by J. Morita USA, Inc. — Product Code EKX

K173920 is an FDA 510(k) premarket notification submitted by J. Morita USA, Inc. for the device "LS OIL". The FDA issued a decision of Substantially Equivalent on October 11, 2018. The device falls under product code EKX (Handpiece, Direct Drive, Ac-Powered), a Class I device regulated under 21 CFR 872.4200. J. Morita USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 11, 2018
Date Received
December 22, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type