510(k) · Cleared
ClearedMicro-current Wrinkle Reduction Facial service, model EP-400
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li-Tek Electronic Technology Corporation · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Feb 3, 2017 as substantially equivalent to K130065 (Biosonic Technologies, LLC, 2014) and 3 other predicates after a 189-day review. Its family tree reaches back 3 generations to 2001.
- Decided
- Feb 3, 2017
- Review
- 189 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K011935 (2001). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK011935 Rejuvenique Model #RJV10Salton, Inc. · 2001
- 2 generations backK072260 Nuface, Model NU-4003Carol Cole Company · 2007
- 1 generation backK103472 Nuface PlusCarol Cole Company · 2011
- This deviceK162106 Micro-current Wrinkle Reduction Facial service, model EP-400Li-Tek Electronic Technology Corporation · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011935 | Rejuvenique Model #RJV10 | Salton, Inc. | 2001 | — |
| −2 | K072260 | Nuface, Model NU-4003 | Carol Cole Company | 2007 | — |
| −1 | K103472 | Nuface Plus | Carol Cole Company | 2011 | — |
| 0 (this device) | K162106 | Micro-current Wrinkle Reduction Facial service, model EP-400 | Li-Tek Electronic Technology Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K130065 | Beautiful Image Facial Sculpting Device Our reading of the summary gave K130045, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Beautiful Image Model 900 Facial Toning Device”. | 2014 |
| * | K142794 | Everyway Facial MENSSummary page 5…NOFACE® Plus Nutra Light Red Name MENS Toning Device 510(k) K130045 K142794 K103472 K141308 Number Product NFO NFO NFO… | 2015 |
| * | K103472 | Nuface PlusSummary page 5…Nutra Light Red Name MENS Toning Device 510(k) K130045 K142794 K103472 K141308 Number Product NFO NFO NFO OHS… | 2011 |
| * | K141308 | Nutra Light RedSummary page 5…Name MENS Toning Device 510(k) K130045 K142794 K103472 K141308 Number Product NFO NFO NFO OHS Code Regulati… | 2014 |
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 16 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
- None of the 9 ancestors has a recall.
- 4 other devices also cite its predicate K130065.
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. 2017, 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?
The device is intended for facial stimulation by electrode heads for cosmetic use. The device is also intended for the treatment of periorbital wrinkles with red Light Emitting Diode (LED) head. It is for over-the-counter use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162106: Micro-current Wrinkle Reduction Facial service, model EP-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162106
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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