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FDA PMA

Optical diagnostic device for melanoma detection

PMA Number: P090012 · 2016-08-18

ApplicantStrata Skin Sciences, Inc.
Decision Date2016-08-18
PMA NumberP090012
Product CodeOYD
Device ClassClass 2
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeSU

Device Summary

Optical diagnostic device for melanoma detection is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2016-08-18. The device is classified under product code OYD. It was reviewed by the SU advisory panel.

Frequently Asked Questions

What is the Optical diagnostic device for melanoma detection?

Optical diagnostic device for melanoma detection is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Strata Skin Sciences, Inc..

When did Optical diagnostic device for melanoma detection receive FDA 510(k) clearance?

The clearance date for Optical diagnostic device for melanoma detection can be found in the official FDA records.

Who is the listed applicant for Optical diagnostic device for melanoma detection?

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

What is the FDA product code for Optical diagnostic device for melanoma detection?

The FDA product code for Optical diagnostic device for melanoma detection is OYD.

Related Clinical Trials

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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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