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510(k) K240504

PLASMA EDGE System by Lamidey Noury Medical — Product Code FAS

K240504 is an FDA 510(k) premarket notification submitted by Lamidey Noury Medical for the device "PLASMA EDGE System". The FDA issued a decision of Substantially Equivalent on June 12, 2024. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Lamidey Noury Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2024
Date Received
February 21, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrosurgical, Active, Urological
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type

Other clearances by Lamidey Noury Medical

  • K222542 — MCB UNIT Model: V10GMCBUS (September 21, 2022)

Other clearances for product code FAS

  • K251403 — Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Elect (December 5, 2025)
  • K250522 — Multi4 System (June 27, 2025)
  • K213135 — Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, (March 2, 2022)
  • K210651 — Resection Electrodes with HF cable (August 3, 2021)
  • K210394 — Electrosurgical accessory (May 19, 2021)
  • K171965 — Resection Electrodes with HF cable (September 28, 2017)
  • K163090 — Plasma Edge System (May 23, 2017)
  • K151976 — Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode (June 27, 2016)
  • K152092 — Resection Electrodes (October 26, 2015)
  • K120567 — GYRUS AMCI PK BUTTON ELECTRODE (June 20, 2012)

FDA data resources