De Novo · Granted
GrantedNewa Skin Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endymed Medical, Ltd. · PAY Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
Granted on Dec 18, 2015 as a new device type through De Novo after a 336-day review. 9 later devices descend from it.
- Decided
- Dec 18, 2015
- Review
- 336 days
- Class
- Class II
- Product code
- PAY
- Recalls
- None
9 later devices descend from it, 3 citing it directly.
- This deviceDEN150005 Newa Skin Therapy SystemEndymed Medical, Ltd. · 2015
- Descendant · cites it directly · 5 of its ownK182774 STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019
- Descendant · 2 generations on · 4 of its ownK203665 STOP U Model UXV DevicePollogen, Ltd. · 2021
- Descendant · 3 generations on · 3 of its ownK220322 Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK170499 sensiLiftEl Global Trade, Ltd. · 2017
- Descendant · cites it directly · 1 of its ownK162784 Silk'n HSTHome Skinovations, Ltd. · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K182774STOP U (Packed Black USA), STOP U (Packed White USA)Pollogen, Ltd. · 2019 · cites it directly5descendants
- K203665STOP U Model UXV DevicePollogen, Ltd. · 2021 · 2 generations on4descendants
- K220322Pollogen STOP U Model UXV DevicePollogen, Ltd. · 2023 · 3 generations on3descendants
- K170499sensiLiftEl Global Trade, Ltd. · 2017 · cites it directly1descendant
- K162784Silk'n HSTHome Skinovations, Ltd. · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150005 | Newa Skin Therapy System | Endymed Medical, Ltd. | 2015 | — |
| +1 | K182774 | STOP U (Packed Black USA), STOP U (Packed White USA) | Pollogen, Ltd. | 2019 | — |
| +2 | K203665 | STOP U Model UXV Device | Pollogen, Ltd. | 2021 | — |
| +3 | K220322 | Pollogen STOP U Model UXV Device | Pollogen, Ltd. | 2023 | — |
| +1 | K170499 | sensiLift | El Global Trade, Ltd. | 2017 | — |
| +1 | K162784 | Silk'n HST | Home Skinovations, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA De Novo 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K182774 (Pollogen, Ltd., 2019) has gone furthest, with 5 descendants of its own.
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. 2015, 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 EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women with Fitzpatrick Skin Types I-IV.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150005 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN150005: Newa Skin Therapy System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN150005
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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