Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LightForce Orthodontic System (LFO System)

K-Number: K200148 · 2020-02-21

ApplicantLightforce Orthodontics
Decision Date2020-02-21
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LightForce Orthodontic System (LFO System) is the device name listed in this FDA 510(k) record. The listed applicant is Lightforce Orthodontics. It received FDA 510(k) clearance on 2020-02-21 under 510(k) number K200148. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LightForce Orthodontic System (LFO System)?

LightForce Orthodontic System (LFO System) is a medical device that received FDA 510(k) clearance on 2020-02-21. The listed applicant is Lightforce Orthodontics. The 510(k) number is K200148.

When did LightForce Orthodontic System (LFO System) receive FDA 510(k) clearance?

LightForce Orthodontic System (LFO System) received FDA 510(k) clearance on 2020-02-21, under 510(k) number K200148.

Who is the listed applicant for LightForce Orthodontic System (LFO System)?

The FDA 510(k) record lists Lightforce Orthodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightForce Orthodontic System (LFO System)?

The FDA product code for LightForce Orthodontic System (LFO System) is NJM.

Other records listing Lightforce Orthodontics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232827LightForce Orthodontic SystemK222764LightForce Orthodontic System

Related Devices (Code: NJM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232827LightForce Orthodontic SystemLightforce OrthodonticsK232011CleoAmerican OrthodonticsK231635A-Line AdvancedBiocetec Co., Ltd.K230225DynaFlex Clear Brackets & ButtonsDyna FlexK222847Ceramic Brackets OrthometricOrthometric - Industria E Comercio DE Produtos MedicosK222764LightForce Orthodontic SystemLightforce Orthodontics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑