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FDA 510(k)

Diosculpt

K-Number: K222265 · 2022-09-23

ApplicantShanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Decision Date2022-09-23
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diosculpt is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2022-09-23 under 510(k) number K222265. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diosculpt?

Diosculpt is a medical device that received FDA 510(k) clearance on 2022-09-23. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K222265.

When did Diosculpt receive FDA 510(k) clearance?

Diosculpt received FDA 510(k) clearance on 2022-09-23, under 510(k) number K222265.

Who is the listed applicant for Diosculpt?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diosculpt?

The FDA product code for Diosculpt is PKT.

Other records listing Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as applicant

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Related Devices (Code: PKT)

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.

K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd.K233962ReBorn (1050nm)Lightfective , Ltd.K231971DEKA PHYSIQ 360El.En S.P.A.K231131Diode Laser Body Sculpture SystemsShanghai Bele Medical Technology Co.,LtdK222226EONDominion Aesthetic Technologies, Inc.K211681EONDominion Aesthetic Technologies, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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