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FDA 510(k)

DERMILLUME RED, MODEL HR1000

K-Number: K051681 · 2005-07-27

ApplicantCare Electronics, Inc.
Decision Date2005-07-27
Product CodeILY
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

DERMILLUME RED, MODEL HR1000 is the device name listed in this FDA 510(k) record. The listed applicant is Care Electronics, Inc.. It received FDA 510(k) clearance on 2005-07-27 under 510(k) number K051681. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMILLUME RED, MODEL HR1000?

DERMILLUME RED, MODEL HR1000 is a medical device that received FDA 510(k) clearance on 2005-07-27. The listed applicant is Care Electronics, Inc.. The 510(k) number is K051681.

When did DERMILLUME RED, MODEL HR1000 receive FDA 510(k) clearance?

DERMILLUME RED, MODEL HR1000 received FDA 510(k) clearance on 2005-07-27, under 510(k) number K051681.

Who is the listed applicant for DERMILLUME RED, MODEL HR1000?

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

What is the FDA product code for DERMILLUME RED, MODEL HR1000?

The FDA product code for DERMILLUME RED, MODEL HR1000 is ILY.

Related Clinical Trials

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Other records listing Care Electronics, 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.

K043575DERMILLUME, MODEL PRO1000K925529WANDER CARE

Related Devices (Code: ILY)

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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