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FDA 510(k)

INMODE SR IPL DEVICE

K-Number: K123860 · 2013-04-02

ApplicantInmode MD , Ltd.
Decision Date2013-04-02
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INMODE SR IPL 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 2013-04-02 under 510(k) number K123860. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INMODE SR IPL DEVICE?

INMODE SR IPL DEVICE is a medical device that received FDA 510(k) clearance on 2013-04-02. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K123860.

When did INMODE SR IPL DEVICE receive FDA 510(k) clearance?

INMODE SR IPL DEVICE received FDA 510(k) clearance on 2013-04-02, under 510(k) number K123860.

Who is the listed applicant for INMODE SR IPL 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 SR IPL DEVICE?

The FDA product code for INMODE SR IPL DEVICE is ONF.

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Other records listing Inmode MD , Ltd. as applicant

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Related Devices (Code: ONF)

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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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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