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510(k) K243764

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) by Wuhan Pioon Technology Co., Ltd. — Product Code NVK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2025
Date Received
December 6, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Dental, Soft Tissue
Device Class
Class II
Regulation Number
878.4810
Review Panel
DE
Submission Type

Intended for the incision, excision, cutting, ablation, and vaporization of soft tissue in oral and maxillofacial surgery and dentistry.

Other clearances by Wuhan Pioon Technology Co., Ltd.

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  • K240644 — Medical Diode Laser (S1Pro) (June 10, 2024)
  • K240179 — Medical Diode Laser (Model: L2) (March 21, 2024)
  • K231548 — Medical Diode Laser, Model S1Pro (August 3, 2023)
  • K230274 — Medical Diode Laser (M2) (March 31, 2023)

Other clearances for product code NVK

  • K260765 — Gemini NOVA 810+980 Soft Tissue Laser (March 10, 2026)
  • K250731 — MateLaser Medical Diode Laser Systems (ML-DLS-30) (October 16, 2025)
  • K230047 — Medical Diode Laser Systems (March 4, 2024)
  • K232885 — Dawn Diode Laser System (February 28, 2024)
  • K232222 — Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Trip (November 27, 2023)
  • K221761 — Solea (September 14, 2022)
  • K211150 — Dental diode laser, SOGA Laser, ILaser II (July 1, 2022)
  • K214008 — Dental diode laser (May 10, 2022)
  • K213658 — DEKA SMARTPERIO (March 11, 2022)
  • K210367 — D-Laser Blue, D-Laser 16 (March 10, 2022)