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FDA 510(k)

TR-100

K-Number: K161551 · 2016-09-13

ApplicantBTL Industries, Inc.
Decision Date2016-09-13
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TR-100 is a medical device manufactured by BTL Industries, Inc.. It received FDA 510(k) clearance on 2016-09-13 under approval number K161551. 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 TR-100?

TR-100 is a medical device that received FDA 510(k) clearance on 2016-09-13. It is manufactured by BTL Industries, Inc.. The 510(k) number is K161551.

When was TR-100 approved by the FDA?

TR-100 received FDA 510(k) clearance on 2016-09-13, under approval number K161551.

What company makes TR-100?

TR-100 is manufactured by BTL Industries, Inc..

What is the FDA product code for TR-100?

The FDA product code for TR-100 is PBX.

Other Devices by BTL Industries, Inc.

K162010HPM-6000U K160992HPM-6000 K152731XP1100 RF K163165AM-100 K163176Exilis XP II K180359BTL-FR2000

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Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161458Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep CareIndiba USA, Inc. K161043Profound SystemSyneron Candela Corporation K160329InMode System MiniFX HandpieceInmode MD , Ltd. K161199EndyMed Contour HandpieceEndymed Medical, Ltd. K153568InMode Plus SystemInmode MD , Ltd.

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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