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510(k) K251031

Fiber Laser Treatment Systems (HS-232,HS-233) by Shanghai Apolo Medical Technology Co., Ltd. — Product Code ONG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 2025
Date Received
April 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Powered Laser Surgical Instrument With MicrobeamFractional Output
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

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.

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

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  • K203395 — Platform treatment system (January 28, 2022)
  • K201731 — Diode Laser Body Sculpture System (September 10, 2020)
  • K201109 — CO2 Laser Therapy System (July 15, 2020)
  • K200116 — PicoSecond Nd: YAG Laser System (May 28, 2020)
  • K200746 — IPL Treatment Systems (May 15, 2020)
  • K200118 — Diode Laser Therapy Device (April 17, 2020)
  • K191349 — 980nm Diode Laser Therapy Device (August 16, 2019)
  • K190938 — Phototherapy System (June 26, 2019)

Other clearances for product code ONG

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  • K244060 — eCO2 3D (July 31, 2025)
  • K250402 — AVAVA™ Skin Treatment System (April 14, 2025)
  • K233550 — MOSAIC 3D (Surgical Laser) (January 2, 2024)
  • K223871 — Miria Skin Treatment System (June 22, 2023)
  • K221268 — SR-1 Skin Treatment System (November 21, 2022)
  • K221770 — Fiber Laser Treatment System (October 13, 2022)
  • K213332 — Multifrax Laser System (June 3, 2022)
  • K202884 — SR-1 Skin Treatment System (April 13, 2021)
  • K192350 — Medical Non-Ablative Fractional Laser Systems (April 30, 2020)