510(k) · Cleared
ClearedSmart Photon Micro-current Device, Model: EP-300
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 Oct 25, 2017 as substantially equivalent to K130065 (Biosonic Technologies, LLC, 2014) and 3 other predicates after a 397-day review. Its family tree reaches back 11 generations to 1995. 10 later devices descend from it.
- Decided
- Oct 25, 2017
- Review
- 397 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K943450 (1995). 105 ancestors in all, the oldest K800617 (1980). 10 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK162652 Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation · 2017
- Descendant · cites it directly · 5 of its ownK241102 Luna 4 plusForeo, Inc. · 2024
- Descendant · cites it directly · 4 of its ownK213039 Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK243423 LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G…Shenzhen Rainbow Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 3 of its ownK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 3 generations on · 1 of its ownK253712 LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062…Shenzhen Rainbow Technology Co., Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- This deviceK162652 Smart Photon Micro-current Device, Model: EP-300Li-Tek Electronic Technology Corporation · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K241102Luna 4 plusForeo, Inc. · 2024 · cites it directly5descendants
- K213039Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd. · 2022 · cites it directly4descendants
- K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd. · 2025 · 2 generations on3descendants
- K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · 2 generations on3descendants
- K253712LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063…Shenzhen Rainbow Technology Co., Ltd. · 2026 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −1 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| 0 (this device) | K162652 | Smart Photon Micro-current Device, Model: EP-300 | Li-Tek Electronic Technology Corporation | 2017 | — |
| +1 | K241102 | Luna 4 plus | Foreo, Inc. | 2024 | — |
| +1 | K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | 2022 | — |
| +2 | K243423 | LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB… | Shenzhen Rainbow Technology Co., Ltd. | 2025 | — |
| +2 | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +3 | K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072… | Shenzhen Rainbow Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 DeviceSummary page 5…ue Nutra Light Red Model 900 Facial Name MENS Toning Device 510(k) K130065 K142794 K121435 K141308 Number Product NFO NFO… | 2014 |
| * | K142794 | Everyway Facial MENSSummary page 5…ght Red Model 900 Facial Name MENS Toning Device 510(k) K130065 K142794 K121435 K141308 Number Product NFO NFO OLP… | 2015 |
| * | K121435 | Silkn BlueSummary page 5…Model 900 Facial Name MENS Toning Device 510(k) K130065 K142794 K121435 K141308 Number Product NFO NFO OLP OHS… | 2013 |
| * | K141308 | Nutra Light RedSummary page 5…Name MENS Toning Device 510(k) K130065 K142794 K121435 K141308 Number Product NFO NFO OLP OHS Code Regulation… | 2014 |
What descends from it? (10)
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 22 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 105 ancestors have a recall of any class.
- Of its descendants, K241102 (Foreo, Inc., 2024) has gone furthest, with 5 descendants of its own.
- 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?
For micro current stimulation mode: The Smart Photon Micro-current Device is intended for facial stimulation and is indicated for over-the-counter aesthetic use.
For red light irradiation mode: The red light is intended for the treatment of periorbital wrinkles,
For blue light irradiation mode: The blue light is for the treatment of mild to moderate acne.
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/K162652 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162652: Smart Photon Micro-current Device, Model: EP-300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162652
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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