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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 a medical device manufactured by InMode , Ltd.. It received FDA 510(k) clearance on 2024-11-14 under approval 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. It is manufactured by InMode , Ltd.. The 510(k) number is K242598.

When was DEFINE System (AG612444A) approved by the FDA?

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

What company makes DEFINE System (AG612444A)?

DEFINE System (AG612444A) is manufactured by InMode , Ltd..

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

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

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Related Devices (Code: PBX)

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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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