510(k) · Cleared
ClearedAgeless Wonder Facial Muscle Stimulation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Leto Enterprise, Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Jul 30, 2012 as substantially equivalent to K072260 (Carol Cole Company, 2007) after a 160-day review. Its family tree reaches back 2 generations to 2001. 4 later devices descend from it.
- Decided
- Jul 30, 2012
- Review
- 160 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K011935 (2001). 3 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 1 generation backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- This deviceK120511 Ageless Wonder Facial Muscle Stimulation SystemLeto Enterprise, Ltd. · 2012
- Descendant · cites it directly · 3 of its ownK220198 Medi Lift PLUSYa-Man, Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250618 Medi Lift Essential Eye MaskYa-Man, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK244048 Medi Lift MaskYa-Man, Ltd. · 2025
Most influential descendants
Showing 4 of 4 · See all- K220198Medi Lift PLUSYa-Man, Ltd. · 2023 · cites it directly3descendants
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K250618Medi Lift Essential Eye MaskYa-Man, Ltd. · 2025 · cites it directly0descendants
- K244048Medi Lift MaskYa-Man, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −1 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| 0 (this device) | K120511 | Ageless Wonder Facial Muscle Stimulation System | Leto Enterprise, Ltd. | 2012 | — |
| +1 | K220198 | Medi Lift PLUS | Ya-Man, Ltd. | 2023 | — |
| +2 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +1 | K250618 | Medi Lift Essential Eye Mask | Ya-Man, Ltd. | 2025 | — |
| +2 | K244048 | Medi Lift Mask | Ya-Man, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 0 |
| 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 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 |
|---|---|---|---|
| * | K072260 | Nuface, Model NU-4003Summary page 2…er 6 4. Predicate Device Information Sponsor: Carol Cole Company Device: NuFace Facial Toning Device 510(k) Number: K072260 5. Device Description The Ageless Wonder Facial Toning Device is a battery-powered portable EMS device. It applied spec… | 2007 |
What descends from it? (4)
2 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?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K220198 (Ya-Man, Ltd., 2023) has gone furthest, with 3 descendants of its own.
- 7 other devices also cite its predicate K072260.
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. 2012, 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?
Ageless Wonder Facial Muscle Stimulation System is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120511: Ageless Wonder Facial Muscle Stimulation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120511
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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