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FDA 510(k)

LYSTA LC CURING LIGHT, MODEL LC 2500C/BA

K-Number: K991138 · 1999-04-23

ApplicantLysta A/S
Decision Date1999-04-23
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LYSTA LC CURING LIGHT, MODEL LC 2500C/BA is the device name listed in this FDA 510(k) record. The listed applicant is Lysta A/S. It received FDA 510(k) clearance on 1999-04-23 under 510(k) number K991138. 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 LYSTA LC CURING LIGHT, MODEL LC 2500C/BA?

LYSTA LC CURING LIGHT, MODEL LC 2500C/BA is a medical device that received FDA 510(k) clearance on 1999-04-23. The listed applicant is Lysta A/S. The 510(k) number is K991138.

When did LYSTA LC CURING LIGHT, MODEL LC 2500C/BA receive FDA 510(k) clearance?

LYSTA LC CURING LIGHT, MODEL LC 2500C/BA received FDA 510(k) clearance on 1999-04-23, under 510(k) number K991138.

Who is the listed applicant for LYSTA LC CURING LIGHT, MODEL LC 2500C/BA?

The FDA 510(k) record lists Lysta A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LYSTA LC CURING LIGHT, MODEL LC 2500C/BA?

The FDA product code for LYSTA LC CURING LIGHT, MODEL LC 2500C/BA 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.

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Other records listing Lysta A/S 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.

K992236LYSTA LC COMPACTA CURING LIGHT, MODELS LC 2500 COMPACTA, LC 4000 COMPACTA, LC 6000 COMPACTA & LC 8000 COMPATCA

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

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

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