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510(k) DEN120019

CEFALY by Stx-Med Sprl — Product Code PCC

DEN120019 is an FDA 510(k) premarket notification submitted by Stx-Med Sprl for the device "CEFALY". The FDA issued a decision of De Novo Granted on March 11, 2014. The device falls under product code PCC (Stimulator, Nerve, Electrical, Transcutaneous, For Migraine), a Class II device regulated under 21 CFR 882.5891.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 11, 2014
Date Received
December 13, 2012
Clearance Type
Post-NSE
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class
Class II
Regulation Number
882.5891
Review Panel
NE
Submission Type

Used to apply an electrical current to a patient's cranium through electrodes placed on the skin.

Other clearances for product code PCC

  • K254216 — Enso for Migraine (April 16, 2026)
  • K242719 — ELEXIR 2.0 (ALLIVE3) (November 6, 2024)
  • K234029 — CEFALY Connected - OTC, CEFALY Connected - Rx (July 18, 2024)
  • K232749 — DOOPANG (June 11, 2024)
  • K233751 — Milieve (YPS-301BD) (June 3, 2024)
  • K230782 — TENS device-HeadaTerm 2 (Model: YF-HT2) (February 26, 2024)
  • K212071 — Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefal (December 13, 2022)
  • K212106 — Relivion (August 2, 2021)
  • K211380 — Elexir (July 30, 2021)
  • K210364 — Migraine Tens Digital Pain Reliever (June 17, 2021)

FDA data resources