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FDA 510(k)

Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT

K-Number: K980793 · 1998-05-15

ApplicantRolence Enterprise Co. , Ltd.
Decision Date1998-05-15
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Q-LUXPRO V/Q-LUXPRO II 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 1998-05-15 under 510(k) number K980793. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT?

Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT is a medical device that received FDA 510(k) clearance on 1998-05-15. The listed applicant is Rolence Enterprise Co. , Ltd.. The 510(k) number is K980793.

When did Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT receive FDA 510(k) clearance?

Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT received FDA 510(k) clearance on 1998-05-15, under 510(k) number K980793.

Who is the listed applicant for Q-LUXPRO V/Q-LUXPRO II 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-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT?

The FDA product code for Q-LUXPRO V/Q-LUXPRO II LIGHT CURE UNIT is EBF.

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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.

K001719Q-LUX PLASMA 100 LIGHT CURE UNITK991865Q-LITE 75 LIGHT CURE UNITK991863CUTE-LITE I LIGHT CURE UNITK980792CU-100A LIGHT CURE UNITK960351Q-LUX LIGHT CURE UNITK960364CU-200 LIGHT CURE UNIT

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Related Devices (Code: EBF)

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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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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