510(k) · Cleared
ClearedTheraFace LED
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Theragun, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Dec 21, 2021 as substantially equivalent to K171821 (Heat IN A Click, 2018) and 1 other predicate after a 162-day review. Its family tree reaches back 15 generations to 1995. 42 later devices descend from it.
- Decided
- Dec 21, 2021
- Review
- 162 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 158 ancestors in all, the oldest K800617 (1980). 42 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 deviceK212155 TheraFace LEDTheragun, Inc. · 2021
- Descendant · cites it directly · 39 of its ownK223544 LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023
- Descendant · 2 generations on · 21 of its ownK241857 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024
- Descendant · 3 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
- Descendant · cites it directly · 5 of its ownK241102 Luna 4 plusForeo, Inc. · 2024
- Descendant · 2 generations on · 3 of its ownK242385 LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd. · 2025
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 deviceK212155 TheraFace LEDTheragun, Inc. · 2021
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K223544LED light therapy mask (FM-01, FM-02, FM-03)Guangdong Newdermo Biotech Co., Ltd. · 2023 · cites it directly39descendants
- K241857LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)Dongguan Boyuan Intelligent Technology Co.,Ltd · 2024 · 2 generations on21descendants
- 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 · 3 generations on6descendants
- K241102Luna 4 plusForeo, Inc. · 2024 · cites it directly5descendants
- K242385LED Therapy Mask (MN1, M226)Shenzhen Borria Technology Co., Ltd. · 2025 · 2 generations on3descendants
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) | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| +1 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | Guangdong Newdermo Biotech Co., Ltd. | 2023 | — |
| +2 | K241857 | LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) | Dongguan Boyuan Intelligent Technology Co.,Ltd | 2024 | — |
| +3 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +1 | K241102 | Luna 4 plus | Foreo, Inc. | 2024 | — |
| +2 | K242385 | LED Therapy Mask (MN1, M226) | Shenzhen Borria Technology Co., Ltd. | 2025 | — |
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 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 25 | 0 |
| 2026 | 12 | 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 OHS? 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 OHS device
- #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 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 |
|---|---|---|---|
| * | K171821 | 2 Face / Face EvolutionSummary page 4…Electronic Products Co., Ltd. Device Name and 2 Face / Face Evolution RED Light Device Model 510(k) Number K171821 (Primary Predicate) K162489 Product Code OHS, OLP OHS Regulation Number… | 2018 |
| * | K162489 | RED Light DeviceSummary page 4…ducts Co., Ltd. Device Name and 2 Face / Face Evolution RED Light Device Model 510(k) Number K171821 (Primary Predicate) K162489 Product Code OHS, OLP OHS Regulation Number 878.4810… | 2017 |
What descends from it? (42)
See all 422 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 26 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 158 ancestors have a recall of any class.
- Of its descendants, K223544 (Guangdong Newdermo Biotech Co., Ltd., 2023) has gone furthest, with 39 descendants of its own.
- 8 other devices also cite its predicate K171821.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The device can work in multiple function modes as following with different indication for use:
1) The red light is intended to treat periorbital wrinkles.
2) The blue light is intended to treat mild to moderate inflammatory acne.
3) The Red + IR is intended to treat periorbital wrinkles.
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/K212155 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212155: TheraFace LED.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212155
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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