510(k) · Cleared
ClearedPureLift Pro Max
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xtreem Pulse, LLC · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Sep 11, 2026 as substantially equivalent to K221443 (Xtreem Pulse, LLC, 2022) after a 29-day review. Its family tree reaches back 4 generations to 2001.
- Decided
- Sep 11, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011935 (2001). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 3 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 2 generations backK190269 PureLiftXtreem Pulse, LLC · 2019
- 1 generation backK221443 PureLift Pro PlusXtreem Pulse, LLC · 2022
- This deviceK262861 PureLift Pro MaxXtreem Pulse, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −3 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −2 | K190269 | PureLift | Xtreem Pulse, LLC | 2019 | — |
| −1 | K221443 | PureLift Pro Plus | Xtreem Pulse, LLC | 2022 | — |
| 0 (this device) | K262861 | PureLift Pro Max | Xtreem Pulse, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
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 NFO? 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 NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 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 |
|---|---|---|---|
| * | K221443 | PureLift Pro PlusSummary page 5…lator, Transcutaneous Electrical, Aesthetic Purposes Regulation Number: 21 CFR 882.5890 Product Code: NFO Predicate and Reference Devices K221443 PureLift Pro Plus (Xtreem Pulse, LLC) K011935 Rejuvenique Facial Toning System (Salt… | 2022 |
| † | K011935 | Rejuvenique Model #RJV10 | 2001 |
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 25 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 5 ancestors has a recall.
- 5 other devices also cite its predicate K221443.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
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/K262861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262861: PureLift Pro Max.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262861
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026