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FDA 510(k)

BeShape One™ Device

K-Number: K231628 · 2023-09-29

ApplicantBeshape Technologies , Ltd.
Decision Date2023-09-29
Product CodeOHV
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BeShape One™ Device is the device name listed in this FDA 510(k) record. The listed applicant is Beshape Technologies , Ltd.. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231628. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BeShape One™ Device?

BeShape One™ Device is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Beshape Technologies , Ltd.. The 510(k) number is K231628.

When did BeShape One™ Device receive FDA 510(k) clearance?

BeShape One™ Device received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231628.

Who is the listed applicant for BeShape One™ Device?

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

What is the FDA product code for BeShape One™ Device?

The FDA product code for BeShape One™ Device is OHV.

Related Devices (Code: OHV)

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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