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FDA 510(k)

IMAGINE TC SKIN THERAPY SYSTEM

K-Number: K083461 · 2009-07-24

ApplicantEndymion Medical, Ltd.
Decision Date2009-07-24
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IMAGINE TC SKIN THERAPY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Endymion Medical, Ltd.. It received FDA 510(k) clearance on 2009-07-24 under 510(k) number K083461. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGINE TC SKIN THERAPY SYSTEM?

IMAGINE TC SKIN THERAPY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-07-24. The listed applicant is Endymion Medical, Ltd.. The 510(k) number is K083461.

When did IMAGINE TC SKIN THERAPY SYSTEM receive FDA 510(k) clearance?

IMAGINE TC SKIN THERAPY SYSTEM received FDA 510(k) clearance on 2009-07-24, under 510(k) number K083461.

Who is the listed applicant for IMAGINE TC SKIN THERAPY SYSTEM?

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

What is the FDA product code for IMAGINE TC SKIN THERAPY SYSTEM?

The FDA product code for IMAGINE TC SKIN THERAPY SYSTEM is GEI.

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.

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Other records listing Endymion Medical, Ltd. 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.

K130793NEWA SKIN THERAPY SYSTEM

Related Devices (Code: GEI)

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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