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FDA 510(k)

LEVO COMFORT II

K-Number: K051387 · 2005-06-10

ApplicantLevo AG
Decision Date2005-06-10
Product CodeIPL
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

LEVO COMFORT II is the device name listed in this FDA 510(k) record. The listed applicant is Levo AG. It received FDA 510(k) clearance on 2005-06-10 under 510(k) number K051387. 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 COMFORT II?

LEVO COMFORT II is a medical device that received FDA 510(k) clearance on 2005-06-10. The listed applicant is Levo AG. The 510(k) number is K051387.

When did LEVO COMFORT II receive FDA 510(k) clearance?

LEVO COMFORT II received FDA 510(k) clearance on 2005-06-10, under 510(k) number K051387.

Who is the listed applicant for LEVO COMFORT II?

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

What is the FDA product code for LEVO COMFORT II?

The FDA product code for LEVO COMFORT II is IPL.

Related Clinical Trials

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Other records listing Levo AG 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.

K083017LEVO C3K030893LEVO COMBI

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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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