510(k) · Cleared
ClearedsensiLift
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El Global Trade, Ltd. · PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Cleared on Jun 15, 2017 as substantially equivalent to DEN150005 (Endymed Medical, Ltd., 2015) after a 118-day review. Its family tree reaches back 1 generation to 2015. 1 later device descends from it.
- Decided
- Jun 15, 2017
- Review
- 118 days
- Class
- Class II
- Product code
- PAY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150005 (2015). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K250341Sensilift Pro (ST300XXYYZZZ)El Global Trade, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | 2015 | — |
| 0 (this device) | K170499 | sensiLift | El Global Trade, Ltd. | 2017 | — |
| +1 | K250341 | Sensilift Pro (ST300XXYYZZZ) | El Global Trade, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 PAY? 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 PAY device
- #1 K220322 Pollogen STOP U Model UXV Devicescore 20.0 · 20 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 |
|---|---|---|---|
| * | DEN150005 | Newa Skin Therapy SystemSummary page 4…sensiLift device is substantially equivalent to the following Predicate Device: 3.1 EndyMed Medical Ltd.'s NEWA device, cleared under De-Novo number DEN150005 at Dec 18th, 2016. 4. DEVICE DESCRIPTION The sensiLift is an OTC, home use hand held device generating pulses of… | 2015 |
| † | K140527 | Sensilight Mini | 2014 |
| † | K161089 | sensiLight Mini | 2016 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250341 | Sensilift Pro (ST300XXYYZZZ) | 2026 | 0 |
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?
How does its category compare?
All PAY devicesPAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PAY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PAY
165in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PAY
No recall names PAY since 2007.
Adverse event reports per year · PAY
2in 2025
MAUDE reports naming product code PAY, 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 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 3 | 271 | 0 | 1 |
| 2024 | 3 | 165 | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170499 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170499: sensiLift.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170499
Report an extraction error
Are you the manufacturer?
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