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FDA 510(k)

KREATIV KURING LIGHT SYSTEM

K-Number: K962376 · 1997-03-21

ApplicantKreativ, Inc.
Decision Date1997-03-21
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KREATIV KURING LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Kreativ, Inc.. It received FDA 510(k) clearance on 1997-03-21 under 510(k) number K962376. 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 KREATIV KURING LIGHT SYSTEM?

KREATIV KURING LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-21. The listed applicant is Kreativ, Inc.. The 510(k) number is K962376.

When did KREATIV KURING LIGHT SYSTEM receive FDA 510(k) clearance?

KREATIV KURING LIGHT SYSTEM received FDA 510(k) clearance on 1997-03-21, under 510(k) number K962376.

Who is the listed applicant for KREATIV KURING LIGHT SYSTEM?

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

What is the FDA product code for KREATIV KURING LIGHT SYSTEM?

The FDA product code for KREATIV KURING LIGHT SYSTEM is EBF.

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 Kreativ, Inc. 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.

K990060MACH 7K983227POWER BLOCKK980216KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6K940776KREATIV MODEL KV-1

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, Inc.

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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