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FDA 510(k)

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI

K-Number: K032465 · 2003-10-21

ApplicantSatelec
Decision Date2003-10-21
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI is the device name listed in this FDA 510(k) record. The listed applicant is Satelec. It received FDA 510(k) clearance on 2003-10-21 under 510(k) number K032465. 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 MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI?

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI is a medical device that received FDA 510(k) clearance on 2003-10-21. The listed applicant is Satelec. The 510(k) number is K032465.

When did MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI receive FDA 510(k) clearance?

MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI received FDA 510(k) clearance on 2003-10-21, under 510(k) number K032465.

Who is the listed applicant for MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI?

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

What is the FDA product code for MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI?

The FDA product code for MINI L.E.D., MODEL: MINI L.E.D., MODEL SMARTLITE MINI is EBZ.

Related Clinical Trials

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Other records listing Satelec 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.

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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.

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