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FDA 510(k)

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2

K-Number: K082819 · 2009-03-20

ApplicantMiramar Labs, Inc.
Decision Date2009-03-20
Product CodeNEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 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 2009-03-20 under 510(k) number K082819. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMATOLOGIC TREATMENT SYSTEM (DTS) G2?

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 is a medical device that received FDA 510(k) clearance on 2009-03-20. The listed applicant is Miramar Labs, Inc.. The 510(k) number is K082819.

When did DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 receive FDA 510(k) clearance?

DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 received FDA 510(k) clearance on 2009-03-20, under 510(k) number K082819.

Who is the listed applicant for DERMATOLOGIC TREATMENT SYSTEM (DTS) G2?

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 DERMATOLOGIC TREATMENT SYSTEM (DTS) G2?

The FDA product code for DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 is NEY.

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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 SYSTEMK103014MIRADRY SYSTEM

Related Devices (Code: NEY)

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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