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FDA 510(k)

INMODE HAIR REMOVAL (HR) DEVICE

K-Number: K123682 · 2013-02-27

ApplicantInmode MD , Ltd.
Decision Date2013-02-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INMODE HAIR REMOVAL (HR) DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2013-02-27 under 510(k) number K123682. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INMODE HAIR REMOVAL (HR) DEVICE?

INMODE HAIR REMOVAL (HR) DEVICE is a medical device that received FDA 510(k) clearance on 2013-02-27. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K123682.

When did INMODE HAIR REMOVAL (HR) DEVICE receive FDA 510(k) clearance?

INMODE HAIR REMOVAL (HR) DEVICE received FDA 510(k) clearance on 2013-02-27, under 510(k) number K123682.

Who is the listed applicant for INMODE HAIR REMOVAL (HR) DEVICE?

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

What is the FDA product code for INMODE HAIR REMOVAL (HR) DEVICE?

The FDA product code for INMODE HAIR REMOVAL (HR) DEVICE is GEX. This falls under the Gastroenterology category.

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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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