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FDA 510(k)

Diode Laser Body Sculpture Systems

K-Number: K231131 · 2023-06-22

ApplicantShanghai Bele Medical Technology Co.,Ltd
Decision Date2023-06-22
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Body Sculpture Systems is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-06-22 under 510(k) number K231131. 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 Diode Laser Body Sculpture Systems?

Diode Laser Body Sculpture Systems is a medical device that received FDA 510(k) clearance on 2023-06-22. The listed applicant is Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K231131.

When did Diode Laser Body Sculpture Systems receive FDA 510(k) clearance?

Diode Laser Body Sculpture Systems received FDA 510(k) clearance on 2023-06-22, under 510(k) number K231131.

Who is the listed applicant for Diode Laser Body Sculpture Systems?

The FDA 510(k) record lists Shanghai Bele Medical Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode Laser Body Sculpture Systems?

The FDA product code for Diode Laser Body Sculpture Systems is PKT.

Other records listing Shanghai Bele Medical Technology Co.,Ltd as applicant

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.

K240474Multi-function Platform Systems (BL-M10)K240386Picosecond Nd:YAG Laser Systems (BL-C10)

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.K222226EONDominion Aesthetic Technologies, Inc.K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,LtdK211681EONDominion 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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