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)

LA500 BLUE LIGHT

K-Number: K033201 · 2003-12-02

ApplicantApoza Enterprise Co., Ltd.
Decision Date2003-12-02
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LA500 BLUE LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Apoza Enterprise Co., Ltd.. It received FDA 510(k) clearance on 2003-12-02 under 510(k) number K033201. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LA500 BLUE LIGHT?

LA500 BLUE LIGHT is a medical device that received FDA 510(k) clearance on 2003-12-02. The listed applicant is Apoza Enterprise Co., Ltd.. The 510(k) number is K033201.

When did LA500 BLUE LIGHT receive FDA 510(k) clearance?

LA500 BLUE LIGHT received FDA 510(k) clearance on 2003-12-02, under 510(k) number K033201.

Who is the listed applicant for LA500 BLUE LIGHT?

The FDA 510(k) record lists Apoza Enterprise Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LA500 BLUE LIGHT?

The FDA product code for LA500 BLUE LIGHT is EBZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Apoza Enterprise Co., Ltd. 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.

K070373APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5WK041303LED TURBO-PENK033198APOZA ULTRASONIC SCALER AND EDODONTICS UNIT, SELECTOR U2K040618LED TURBO

Related Devices (Code: EBZ)

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.

K253131Curing Light (M-Cure 6)Guangzhou Rebornendo Medical Instrument Co., Ltd.K253461Demi ProMeta Systems Co., Ltd.K242386BluemoonGenoss Co., Ltd.K243921LED Curing Lights (DB686 HALO)Foshan Coxo Medical Instrument Co., Ltd.K250009LED Curing Light (C01-X, C02-X)Premium Plus (Dongguan) LimitedK241238LOOP™ LED Curing Light System (CLK01)Garrison Dental Solutions, LLC

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.

↑