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FDA 510(k)

EndyMed Contour Handpiece

K-Number: K161199 · 2016-08-01

ApplicantEndymed Medical, Ltd.
Decision Date2016-08-01
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EndyMed Contour Handpiece is the device name listed in this FDA 510(k) record. The listed applicant is Endymed Medical, Ltd.. It received FDA 510(k) clearance on 2016-08-01 under 510(k) number K161199. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EndyMed Contour Handpiece?

EndyMed Contour Handpiece is a medical device that received FDA 510(k) clearance on 2016-08-01. The listed applicant is Endymed Medical, Ltd.. The 510(k) number is K161199.

When did EndyMed Contour Handpiece receive FDA 510(k) clearance?

EndyMed Contour Handpiece received FDA 510(k) clearance on 2016-08-01, under 510(k) number K161199.

Who is the listed applicant for EndyMed Contour Handpiece?

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

What is the FDA product code for EndyMed Contour Handpiece?

The FDA product code for EndyMed Contour Handpiece is PBX.

Other records listing Endymed 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.

K242996EndyMed PRO MAXK222369PURE LaserK161715EndyGel

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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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