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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 the device name listed in this FDA 510(k) record. The listed applicant is Luvo Medical Technologies, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) 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. The listed applicant is Luvo Medical Technologies, Inc.. The 510(k) number is K210129.

When did RF Thermal System receive FDA 510(k) clearance?

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

Who is the listed applicant for RF Thermal System?

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

What is the FDA product code for RF Thermal System?

The FDA product code for RF Thermal System is PBX.

Other records listing Luvo Medical Technologies, Inc. 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.

K212607DarwinK203728DarwinK193446Bare: 808K193072Lucent : IPL

Related Devices (Code: PBX)

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.

K253480Capenergy C Equipments RF C200 and C400 DrakarianCapenergy Medical S.L.K260647SPECCHIOEl.En S.P.A.K253261Apollo Quattro (APQ-10M)Weero Co., Ltd.K252888NeoSculpt PlusS&M Medical Co., Ltd.K250734OptiLUV DevicePollogen, Ltd.K250916WinForth (LM-E470KA)Shenzhen Leaflife Technology Co., 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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