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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 a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-09-10 under approval 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. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K201731.

When was Diode Laser Body Sculpture System approved by the FDA?

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

What company makes Diode Laser Body Sculpture System?

Diode Laser Body Sculpture System is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Shanghai Apolo Medical Technology Co., Ltd.

K191349980nm Diode Laser Therapy Device K190938Phototherapy System K190936Q-Switched Nd: YAG Laser System K201109CO2 Laser Therapy System K200116PicoSecond Nd: YAG Laser System K200746IPL Treatment Systems

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Related Devices (Code: PKT)

K160470SculpSureCynosure, Inc. K171992SculpSureCynosure, Inc. K171111SculpsureCynosure, Inc. K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. K180511Eon FRDominion Aesthetic Technologies, Inc. K182741SculpSureCynosure

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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