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FDA 510(k)

MIRADRY SYSTEM

K-Number: K103014 · 2011-01-28

ApplicantMiramar Labs, Inc.
Decision Date2011-01-28
Product CodeOUB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MIRADRY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Miramar Labs, Inc.. It received FDA 510(k) clearance on 2011-01-28 under 510(k) number K103014. The device is classified under product code OUB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MIRADRY SYSTEM?

MIRADRY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-28. The listed applicant is Miramar Labs, Inc.. The 510(k) number is K103014.

When did MIRADRY SYSTEM receive FDA 510(k) clearance?

MIRADRY SYSTEM received FDA 510(k) clearance on 2011-01-28, under 510(k) number K103014.

Who is the listed applicant for MIRADRY SYSTEM?

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

What is the FDA product code for MIRADRY SYSTEM?

The FDA product code for MIRADRY SYSTEM is OUB.

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 Miramar Labs, 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.

K180396miraDry SystemK160141miraDry SystemK131162MIRADRY SYSTEMK082819DERMATOLOGIC TREATMENT SYSTEM (DTS) G2

Related Devices (Code: OUB)

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.

K131162MIRADRY SYSTEMMiramar Labs, Inc.

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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