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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 a medical device manufactured by Shanghai Bele Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-06-22 under approval 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. It is manufactured by Shanghai Bele Medical Technology Co.,Ltd. The 510(k) number is K231131.

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

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

What company makes Diode Laser Body Sculpture Systems?

Diode Laser Body Sculpture Systems is manufactured by Shanghai Bele Medical Technology Co.,Ltd.

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

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

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Other Devices by Shanghai Bele Medical Technology Co.,Ltd

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

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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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