510(k) · Cleared
ClearedMicro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Aozemei Technology Co., Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Dec 19, 2024 as substantially equivalent to K171821 (Heat IN A Click, 2018) and 2 other predicates after a 44-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- Dec 19, 2024
- Review
- 44 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K943450 (1995). 167 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 2 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 1 generation backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- This deviceK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK252146 Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025
- 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 ownK260767 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial…Kam Yuen Plastic Products, Ltd. · 2026
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 9 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 8 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 7 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 6 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 5 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 4 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 3 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 2 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 1 generation backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- This deviceK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
Most influential descendants
Showing 3 of 3 · See all- K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025 · cites it directly1descendant
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −9 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −8 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −7 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −6 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −5 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −4 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −3 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| −2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| −1 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| 0 (this device) | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +1 | K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003… | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025 | — |
| +2 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +1 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS… | Kam Yuen Plastic Products, Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K171821 | 2 Face / Face EvolutionSummary page 5…Cleared Date NFO, OHS, 1. Heat In A Click 2 Face / Face Evolution K171821 April 26, 2018 OLP M… | 2018 |
| * | K213039 | Micro-current facial cold and hot service (model: TPML-100)Summary page 5…Micro-current vibration Li-Tek Electronics 2. facial cold and hot service NFO, OLP K213039 May 25, 2022 Technology Co., Ltd. Model: TPML-100 3. BELEGA Co., L… | 2022 |
| * | K233010 | Beagank 4T PlusSummary page 5…5, 2022 Technology Co., Ltd. Model: TPML-100 3. BELEGA Co., Ltd. BEAGANK 4T PLUS NFO K233010 Nov. 21, 2023 IV. Device Description The Micro-current Facial Beauty Device is a portable, non-sterile, reusable… | 2023 |
What descends from it? (3)
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 29 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 167 ancestors have a recall of any class.
- Of its descendants, K252146 (Shenzhen Siken 3D Technology Development Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K171821.
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. 2024, 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?
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718)
Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.
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/K243430 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243430: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243430
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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