510(k) · Cleared
ClearedElexir 2.0 (ALLIVE3)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Eyne Co., Ltd. · PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Cleared on Nov 6, 2024 as substantially equivalent to K211380 (Nu Eyne Co., Ltd., 2021) after a 57-day review. Its family tree reaches back 5 generations to 2014.
- Decided
- Nov 6, 2024
- Review
- 57 days
- Class
- Class II
- Product code
- PCC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN120019 (2014). No later device cites it as a predicate yet.
- Root · 5 generations backDEN120019 CefalyStx-Med Sprl · 2014
- 4 generations backK160237 CefalyCefaly Technology · 2016
- 3 generations backK171446 Cefaly AcuteCefaly Technology · 2017
- 2 generations backK173006 Cefaly DualCefaly Technology · 2017
- 1 generation backK211380 ElexirNu Eyne Co., Ltd. · 2021
- This deviceK242719 Elexir 2.0 (ALLIVE3)Nu Eyne Co., Ltd. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN120019 | Cefaly | Stx-Med Sprl | 2014 | — |
| −4 | K160237 | Cefaly | Cefaly Technology | 2016 | — |
| −3 | K171446 | Cefaly Acute | Cefaly Technology | 2017 | — |
| −2 | K173006 | Cefaly Dual | Cefaly Technology | 2017 | — |
| −1 | K211380 | Elexir | Nu Eyne Co., Ltd. | 2021 | — |
| 0 (this device) | K242719 | Elexir 2.0 (ALLIVE3) | Nu Eyne Co., Ltd. | 2024 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PCC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PCC device
- #1 K201895 Cefaly Dualscore 16.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211380 | ElexirSummary page 6…Predicate Device Manufacturer Nu Eyne Co., Ltd. Device Name (Trade Name) ALLIVE2 (ELEXIR) 510(k) Number K211380 Transcutaneous Electrical Nerve Stimulator To Treat Regulation Name… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All PCC devicesPCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PCC
5in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PCC
211in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PCC
No recall names PCC since 2007.
Adverse event reports per year · PCC
2in 2025
MAUDE reports naming product code PCC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | 88 | 0 | 7 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 5 | 211 | 0 | 6 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The ELEXIR 2.0 is indicated for the acute treatment of migraine (Acute mode, frequency 100 Hz) and the prophylactic treatment of episodic migraine (Prevention mode, frequency 60 Hz) in patients 18 years of age or older.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K242719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242719: Elexir 2.0 (ALLIVE3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242719
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026