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510(k) K211380

Elexir by Nu Eyne Co., Ltd. — Product Code PCC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
May 4, 2021
Clearance Type
Traditional
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 by Nu Eyne Co., Ltd.

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  • K242719 — ELEXIR 2.0 (ALLIVE3) (November 6, 2024)
  • K213629 — SMILE (February 12, 2023)
  • K192773 — ALLIVE (December 6, 2019)

Other clearances for product code PCC

  • 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)
  • K210364 — Migraine Tens Digital Pain Reliever (June 17, 2021)
  • K203419 — Relivion (February 16, 2021)
  • K201895 — Cefaly Dual (September 29, 2020)