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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 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 2025-07-02 under 510(k) 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. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K251031.

When did Fiber Laser Treatment Systems (HS-232,HS-233) receive FDA 510(k) clearance?

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

Who is the listed applicant for Fiber Laser Treatment Systems (HS-232,HS-233)?

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

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

Other records listing Shanghai Apolo 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.

K260256Q-Switched Nd: YAG Laser SystemsK260017Picosecond Nd:YAG Laser Systems (Model: HS-298)K232409Electromagnetic Stimulation SystemsK221770Fiber Laser Treatment SystemK203395Platform treatment systemK201731Diode Laser Body Sculpture System

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Related Devices (Code: ONG)

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.

K252155AVAVA™ Skin Treatment SystemAVAVA, Inc.K244060eCO2 3DLutronic CorporationK250402AVAVA™ Skin Treatment SystemAVAVA, Inc.K233550MOSAIC 3D (Surgical Laser)Lutronic AestheticK223871Miria Skin Treatment SystemAVAVA, Inc.K221268SR-1 Skin Treatment SystemAVAVA, Inc.

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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