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FDA 510(k)

RF Thermal System

K-Number: K210129 · 2021-07-20

ApplicantLuvo Medical Technologies, Inc.
Decision Date2021-07-20
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RF Thermal System is a medical device manufactured by Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-20 under approval number K210129. 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 RF Thermal System?

RF Thermal System is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Luvo Medical Technologies, Inc.. The 510(k) number is K210129.

When was RF Thermal System approved by the FDA?

RF Thermal System received FDA 510(k) clearance on 2021-07-20, under approval number K210129.

What company makes RF Thermal System?

RF Thermal System is manufactured by Luvo Medical Technologies, Inc..

What is the FDA product code for RF Thermal System?

The FDA product code for RF Thermal System is PBX.

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Other Devices by Luvo Medical Technologies, Inc.

K193446Bare: 808 K193072Lucent : IPL K212607Darwin K203728Darwin

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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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