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FDA 510(k)

LightForce Orthodontic System

K-Number: K232827 · 2023-09-14

ApplicantLightforce Orthodontics
Decision Date2023-09-14
Product CodeNJM
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LightForce Orthodontic System is a medical device manufactured by Lightforce Orthodontics. It received FDA 510(k) clearance on 2023-09-14 under approval number K232827. 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?

LightForce Orthodontic System is a medical device that received FDA 510(k) clearance on 2023-09-14. It is manufactured by Lightforce Orthodontics. The 510(k) number is K232827.

When was LightForce Orthodontic System approved by the FDA?

LightForce Orthodontic System received FDA 510(k) clearance on 2023-09-14, under approval number K232827.

What company makes LightForce Orthodontic System?

LightForce Orthodontic System is manufactured by Lightforce Orthodontics.

What is the FDA product code for LightForce Orthodontic System?

The FDA product code for LightForce Orthodontic System is NJM.

Related Clinical Trials

NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT05006339 The Use of Remote Monitoring for Orthodontic Retention Review ACTIVE_NOT_RECRUITING NCT05905224 Clinical Trial to Assess the Efficacy of Reducing the Aligners' Wear Protocol COMPLETED NCT07318623 Comparative Outcomes of Damon Ultima vs Pitts 21 Pro Bracket Systems NOT_YET_RECRUITING NCT07264127 Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment RECRUITING

Other Devices by Lightforce Orthodontics

K200148LightForce Orthodontic System (LFO System) K222764LightForce Orthodontic System

Related Devices (Code: NJM)

K160957CDB Self Ligating Bracket 8FCdb Corporation K160615ORTHODONTIC CERAMIC BRACKETS 1.1Tomy, Inc. K152167BIJOU Orthodontic Ceramic BracketWorld Bio Tech Co., Ltd. K171844Inspire ICE aka Inspire ICE Clear BracketsOrmco Corporation K163467C-Line Orthodontic Ceramic BracketBiocetec Co., Ltd. K163117Alpha PureKoroad America

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.

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