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510(k) K241785

StarFormer (M008-3T) by Fotona D.O.O. — Product Code QPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2025
Date Received
June 20, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electromagnetic Stimulator, Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
PM
Submission Type

Intended to apply a magnetic-field induced electrical current to treat pain.

Other clearances by Fotona D.O.O.

  • K242202 — LightWalker Laser System Family (August 23, 2024)
  • K234061 — StarFormer (July 1, 2024)
  • K221274 — StarFormer, TightWave (September 29, 2023)
  • K223540 — AvalancheLase Family (January 19, 2023)
  • K221712 — Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) (October 12, 2022)
  • K213267 — Dynamis Pro Family (September 8, 2022)
  • K202991 — Fotona XPulse Pro Laser Platform (June 22, 2021)
  • K202985 — LightWalker Laser System Family (March 19, 2021)
  • K202172 — StarWalker (November 19, 2020)
  • K193656 — SkyPulse (March 27, 2020)

Other clearances for product code QPL

  • K250309 — BTL-199 (August 7, 2025)
  • K250286 — Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super (July 3, 2025)
  • K233364 — Axon Therapy (January 10, 2024)
  • K230014 — MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, Mag (August 25, 2023)
  • K210021 — Axon Therapy (June 11, 2021)