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FDA 510(k)

DERMAWAVE 5000 COMBI MAX SYSTEM

K-Number: K040121 · 2004-03-17

ApplicantDermawave, LLC
Decision Date2004-03-17
Product CodeIMG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DERMAWAVE 5000 COMBI MAX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dermawave, LLC. It received FDA 510(k) clearance on 2004-03-17 under 510(k) number K040121. The device is classified under product code IMG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMAWAVE 5000 COMBI MAX SYSTEM?

DERMAWAVE 5000 COMBI MAX SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-17. The listed applicant is Dermawave, LLC. The 510(k) number is K040121.

When did DERMAWAVE 5000 COMBI MAX SYSTEM receive FDA 510(k) clearance?

DERMAWAVE 5000 COMBI MAX SYSTEM received FDA 510(k) clearance on 2004-03-17, under 510(k) number K040121.

Who is the listed applicant for DERMAWAVE 5000 COMBI MAX SYSTEM?

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

What is the FDA product code for DERMAWAVE 5000 COMBI MAX SYSTEM?

The FDA product code for DERMAWAVE 5000 COMBI MAX SYSTEM is IMG.

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Related Devices (Code: IMG)

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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