510(k) · Cleared
Cleared2 Face / Face Evolution
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heat IN A Click · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Apr 26, 2018 as substantially equivalent to K103472 (Carol Cole Company, 2011) and 1 other predicate after a 311-day review. Its family tree reaches back 14 generations to 1995. 58 later devices descend from it.
- Decided
- Apr 26, 2018
- Review
- 311 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 153 ancestors in all, the oldest K800617 (1980). 58 later devices descend from it, 9 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 2 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 1 generation backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- This deviceK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · cites it directly · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · 2 generations on · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 3 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · cites it directly · 12 of its ownK241718 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 4 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 3 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 2 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 1 generation backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- This deviceK171821 2 Face / Face EvolutionHeat IN A Click · 2018
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K212155TheraFace LEDTheragun, Inc. · 2021 · cites it directly42descendants
- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · 2 generations on39descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 3 generations on21descendants
- K241718Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · cites it directly12descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −4 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −3 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −2 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| −1 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| 0 (this device) | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +1 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +2 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +3 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +1 | K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +2 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
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 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 0 |
| 2025 | 30 | 0 |
| 2026 | 15 | 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? (2)
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 |
|---|---|---|---|
| * | K103472 | Nuface PlusSummary page 5…Technologies Device Name and Model NUFACE® Plus LED Phototherapy (PL-120) 510(k) Number K103472 K162098 Product Code NFO OLP, OHS Regula… | 2011 |
| * | K162098 | LED Phototherapy DeviceSummary page 5…me and Model NUFACE® Plus LED Phototherapy (PL-120) 510(k) Number K103472 K162098 Product Code NFO OLP, OHS Regulation Number… | 2017 |
What descends from it? (58)
See all 589 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212155 | TheraFace LED | 2021 | 42 |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | 2024 | 12 |
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | 2024 | 3 |
| K202055 | Looper (Model: ZX-579S) | 2021 | 3 |
| K243393 | JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) | 2025 | 1 |
| K253833 | Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004… | 2026 | 0 |
| K252187 | Aura Glide (FC40) | 2025 | 0 |
| K232863 | Radiant Renewal Skincare Wand (HD-15, HD-15A) | 2023 | 0 |
| K212238 | TheraFace Microcurrent | 2021 | 0 |
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 23 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 153 ancestors have a recall of any class.
- Of its descendants, K212155 (Theragun, Inc., 2021) has gone furthest, with 42 descendants of its own.
- 9 other devices also cite its predicate K103472.
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. 2018, 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?
2 Face / Face Evolution is a hand-held device for over-the counter aesthetic purposes.
(1) The EMS mode is indicated for facial stimulation;
(2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171821 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171821: 2 Face / Face Evolution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171821
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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