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FDA 510(k)

Q-LUX PLASMA 100 LIGHT CURE UNIT

K-Number: K001719 · 2000-10-10

ApplicantRolence Enterprise Co. , Ltd.
Decision Date2000-10-10
Product CodeEBZ
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Q-LUX PLASMA 100 LIGHT CURE UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Rolence Enterprise Co. , Ltd.. It received FDA 510(k) clearance on 2000-10-10 under 510(k) number K001719. 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 Q-LUX PLASMA 100 LIGHT CURE UNIT?

Q-LUX PLASMA 100 LIGHT CURE UNIT is a medical device that received FDA 510(k) clearance on 2000-10-10. The listed applicant is Rolence Enterprise Co. , Ltd.. The 510(k) number is K001719.

When did Q-LUX PLASMA 100 LIGHT CURE UNIT receive FDA 510(k) clearance?

Q-LUX PLASMA 100 LIGHT CURE UNIT received FDA 510(k) clearance on 2000-10-10, under 510(k) number K001719.

Who is the listed applicant for Q-LUX PLASMA 100 LIGHT CURE UNIT?

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

What is the FDA product code for Q-LUX PLASMA 100 LIGHT CURE UNIT?

The FDA product code for Q-LUX PLASMA 100 LIGHT CURE UNIT is EBZ.

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Other records listing Rolence 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.

K991865Q-LITE 75 LIGHT CURE UNITK991863CUTE-LITE I LIGHT CURE UNITK980793Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNITK980792CU-100A LIGHT CURE UNITK960351Q-LUX LIGHT CURE UNITK960364CU-200 LIGHT CURE UNIT

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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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