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FDA 510(k)

DEFINE System (AG612444A)

K-Number: K242598 · 2024-11-14

ApplicantInMode , Ltd.
Decision Date2024-11-14
Product CodePBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DEFINE System (AG612444A) is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2024-11-14 under 510(k) number K242598. 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 DEFINE System (AG612444A)?

DEFINE System (AG612444A) is a medical device that received FDA 510(k) clearance on 2024-11-14. The listed applicant is InMode , Ltd.. The 510(k) number is K242598.

When did DEFINE System (AG612444A) receive FDA 510(k) clearance?

DEFINE System (AG612444A) received FDA 510(k) clearance on 2024-11-14, under 510(k) number K242598.

Who is the listed applicant for DEFINE System (AG612444A)?

The FDA 510(k) record lists InMode , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFINE System (AG612444A)?

The FDA product code for DEFINE System (AG612444A) is PBX.

Other records listing InMode , Ltd. 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.

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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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