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FDA 510(k)

SKIN PURE

K-Number: K862799 · 1986-11-13

ApplicantNihon Kohden America, Inc.
Decision Date1986-11-13
Product CodeGYB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SKIN PURE is the device name listed in this FDA 510(k) record. The listed applicant is Nihon Kohden America, Inc.. It received FDA 510(k) clearance on 1986-11-13 under 510(k) number K862799. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIN PURE?

SKIN PURE is a medical device that received FDA 510(k) clearance on 1986-11-13. The listed applicant is Nihon Kohden America, Inc.. The 510(k) number is K862799.

When did SKIN PURE receive FDA 510(k) clearance?

SKIN PURE received FDA 510(k) clearance on 1986-11-13, under 510(k) number K862799.

Who is the listed applicant for SKIN PURE?

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

What is the FDA product code for SKIN PURE?

The FDA product code for SKIN PURE is GYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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