Cleared Traditional

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

K251031 · Shanghai Apolo Medical Technology Co., Ltd. · General & Plastic Surgery
Jul 2025
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K251031 is an FDA 510(k) clearance for the Fiber Laser Treatment Systems (HS-232,HS-233), a Powered Laser Surgical Instrument With Microbeamfractional Output (Class II — Special Controls, product code ONG), submitted by Shanghai Apolo Medical Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on July 2, 2025, 90 days after receiving the submission on April 3, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K251031 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 2025
Decision Date July 02, 2025
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code ONG — Powered Laser Surgical Instrument With Microbeamfractional Output
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4810
Definition A Laser (light Amplification By Stimulated Emission Of Radiation) Based Device Having Coherence, Collimated And Typically Monochromatic Radiation. The Laser Output Is In Form Of Tiny Beams In Micro Range. Typically, Indicated To Be Used In Medical Specialties Of General And Plastic Surgery And Of Dermatology/aesthetic To Destroy, Remove Or Coagulate Tissue, Generally Soft Tissue. Indication For Use Can Be General And/or Specific. The Classification Regulation 21 Cfr 878.4810 Describes A Device That Is Carbon Dioxide Or Argon Laser Intended To Cut, Destroy, Remove Or Coagulate Tissue By The Light.