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FDA 510(k)

Collagentex Rx-1

K-Number: K162022 · 2016-12-22

ApplicantTanses Technologies, Inc.
Decision Date2016-12-22
Product CodeNHN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Collagentex Rx-1 is a medical device manufactured by Tanses Technologies, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K162022. The device is classified under product code NHN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Collagentex Rx-1?

Collagentex Rx-1 is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Tanses Technologies, Inc.. The 510(k) number is K162022.

When was Collagentex Rx-1 approved by the FDA?

Collagentex Rx-1 received FDA 510(k) clearance on 2016-12-22, under approval number K162022.

What company makes Collagentex Rx-1?

Collagentex Rx-1 is manufactured by Tanses Technologies, Inc..

What is the FDA product code for Collagentex Rx-1?

The FDA product code for Collagentex Rx-1 is NHN.

Other Devices by Tanses Technologies, Inc.

K152412T-32;T-40;T-44;T-52;T-72;TT-50 K180585Collagentex Rx-6

Related Devices (Code: NHN)

K152196Erchonia EVRLErchonia Corporation K153052Erchonia PL TouchErchonia Corporation K180197Erchonia FX-635Erchonia Corporation K180585Collagentex Rx-6Tanses Technologies, Inc. K171354MR4 LaserMulti Radiance Medical K191257Erchonia EVRLErchonia Corporation

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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