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FDA 510(k)

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care

K-Number: K161458 · 2016-10-03

ApplicantIndiba USA, Inc.
Decision Date2016-10-03
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care is a medical device manufactured by Indiba USA, Inc.. It received FDA 510(k) clearance on 2016-10-03 under approval number K161458. 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 Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care?

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care is a medical device that received FDA 510(k) clearance on 2016-10-03. It is manufactured by Indiba USA, Inc.. The 510(k) number is K161458.

When was Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care approved by the FDA?

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care received FDA 510(k) clearance on 2016-10-03, under approval number K161458.

What company makes Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care?

Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care is manufactured by Indiba USA, Inc..

What is the FDA product code for Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care?

The FDA product code for Indiba Diathermia Radiofrequency Device - Activ; Indiba Diathermia Radiofrequency Device - Deep Care is PBX.

Related Clinical Trials

NCT07590843 Efficacy and Safety of a Novel Monopolar Radiofrequency Device for Mid and Lower Face Rejuvenation COMPLETED NCT07585591 Safety and Efficacy Evaluation of the Xerf Device for Aesthetic Treatments COMPLETED NCT06657365 Safety and Efficacy Evaluation of the Monopolar Radiofrequency Device for the Improvement of Facial Wrinkles COMPLETED NCT07355270 A U.S. Pilot Human Investigation of RadiofrEquency Vapor Ablation System to Evaluate Safety, TOleRability, and Effectiveness for Proximal Intestinal Mucosal Ablation in Patients With Type 2 Diabetes Mellitus (RESTORE-1 Study) RECRUITING NCT07218432 A Study of the TheraBionic P1 Device in Breast Cancer RECRUITING NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Related Devices (Code: PBX)

K162512truSculptCutera, Inc. K161551TR-100BTL Industries, 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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