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FDA 510(k)

LEVO COMPACT-EASY LCE

K-Number: K973951 · 1997-12-23

ApplicantLevo USA
Decision Date1997-12-23
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LEVO COMPACT-EASY LCE is the device name listed in this FDA 510(k) record. The listed applicant is Levo USA. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K973951. The device is classified under product code IPL. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEVO COMPACT-EASY LCE?

LEVO COMPACT-EASY LCE is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Levo USA. The 510(k) number is K973951.

When did LEVO COMPACT-EASY LCE receive FDA 510(k) clearance?

LEVO COMPACT-EASY LCE received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973951.

Who is the listed applicant for LEVO COMPACT-EASY LCE?

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

What is the FDA product code for LEVO COMPACT-EASY LCE?

The FDA product code for LEVO COMPACT-EASY LCE is IPL.

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 Levo USA 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.

K963817LEVO MOBIL LCMK971873LEVO ACTIVE-EASY LAEK963816LEVO COMPACT LC

Related Devices (Code: IPL)

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

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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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