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FDA 510(k)

Fiber Laser Treatment Systems (HS-232,HS-233)

K-Number: K251031 · 2025-07-02

ApplicantShanghai Apolo Medical Technology Co., Ltd.
Decision Date2025-07-02
Product CodeONG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fiber Laser Treatment Systems (HS-232,HS-233) is a medical device manufactured by Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-02 under approval number K251031. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fiber Laser Treatment Systems (HS-232,HS-233)?

Fiber Laser Treatment Systems (HS-232,HS-233) is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K251031.

When was Fiber Laser Treatment Systems (HS-232,HS-233) approved by the FDA?

Fiber Laser Treatment Systems (HS-232,HS-233) received FDA 510(k) clearance on 2025-07-02, under approval number K251031.

What company makes Fiber Laser Treatment Systems (HS-232,HS-233)?

Fiber Laser Treatment Systems (HS-232,HS-233) is manufactured by Shanghai Apolo Medical Technology Co., Ltd..

What is the FDA product code for Fiber Laser Treatment Systems (HS-232,HS-233)?

The FDA product code for Fiber Laser Treatment Systems (HS-232,HS-233) is ONG.

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Related PubMed Literature

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

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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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