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FDA 510(k)

Diode Laser Body Sculpture System

K-Number: K201731 · 2020-09-10

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2020-09-10
Product CodePKT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Body Sculpture System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K201731. 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 System?

Diode Laser Body Sculpture System is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K201731.

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

Diode Laser Body Sculpture System received FDA 510(k) clearance on 2020-09-10, under 510(k) number K201731.

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

The FDA 510(k) record lists Shanghai Apolo 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 System?

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

Other records listing Shanghai Apolo Medical Technology 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.K222265DiosculptShanghai Wonderful Opto-Electrics Tech.Co.,Ltd

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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