Cleared Traditional

LightForce Orthodontic System (LFO System)

K200148 · Lightforce Orthodontics · Dental
Feb 2020
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K200148 is an FDA 510(k) clearance for the LightForce Orthodontic System (LFO System), a Bracket, Ceramic, Orthodontic (Class II — Special Controls, product code NJM), submitted by Lightforce Orthodontics (Cambridge, US). The FDA issued a Cleared decision on February 21, 2020, 30 days after receiving the submission on January 22, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.5470.

Submission Details

510(k) Number K200148 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2020
Decision Date February 21, 2020
Days to Decision 30 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NJM — Bracket, Ceramic, Orthodontic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5470
Definition An Orthodontic Ceramic Bracket Is A Device Composed Of Ceramic, Which Is Intended To Be Bonded To A Tooth, Upon Which An Orthodontic Wire Is Used To Move The Tooth To A New Position.