510(k) · Cleared
ClearedTheraFace Mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Therabody, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Jun 9, 2023 as substantially equivalent to K213184 (Mz Skin, 2021) and 1 other predicate after a 127-day review. Its family tree reaches back 16 generations to 1995. 16 later devices descend from it.
- Decided
- Jun 9, 2023
- Review
- 127 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 16 generations to K943450 (1995). 166 ancestors in all, the oldest K800617 (1980). 16 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 2 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 1 generation backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- This deviceK230293 TheraFace MaskTherabody, Inc. · 2023
- Descendant · cites it directly · 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 · 4 of its ownK242796 CryoGlow (FW3XXXX)Sharkninja Operating, LLC · 2024
- Descendant · 2 generations on · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
- Descendant · cites it directly · 2 of its ownK240360 Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 10 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 9 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 8 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 7 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 6 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 5 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 4 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 3 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 2 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 1 generation backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- This deviceK230293 TheraFace MaskTherabody, Inc. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- 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 · cites it directly6descendants
- K242796CryoGlow (FW3XXXX)Sharkninja Operating, LLC · 2024 · cites it directly4descendants
- K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · 2 generations on2descendants
- K240360Wrinkle Treatment Device (JM2)Shenzhen Qianyu Technology Co., Ltd. · 2024 · cites it directly2descendants
- K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −10 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −9 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −8 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −7 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −6 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −5 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −4 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −3 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −2 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −1 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| 0 (this device) | K230293 | TheraFace Mask | Therabody, Inc. | 2023 | — |
| +1 | 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 | K242796 | CryoGlow (FW3XXXX) | Sharkninja Operating, LLC | 2024 | — |
| +2 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
| +1 | K240360 | Wrinkle Treatment Device (JM2) | Shenzhen Qianyu Technology Co., Ltd. | 2024 | — |
| +2 | K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment 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 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 3 | 0 |
| 2025 | 10 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0Summary page 4…s. Device Name and MZ Skin LightMAX LED Therapy Device RED Light Device Model Supercharged LED Mask 2.0 510(k) Number K213184 (Primary Predicate K192295 (Predicate device) K162489 (Reference device)… | 2021 |
| * | K192295 | PDT-FaceSummary page 4…n LightMAX LED Therapy Device RED Light Device Model Supercharged LED Mask 2.0 510(k) Number K213184 (Primary Predicate K192295 (Predicate device) K162489 (Reference device) device)… | 2020 |
| † | K162489 | RED Light Device | 2017 |
What descends from it? (16)
See all 165 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A… | 2024 | 6 |
| K242796 | CryoGlow (FW3XXXX) | 2024 | 4 |
| K240360 | Wrinkle Treatment Device (JM2) | 2024 | 2 |
| K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty… | 2026 | 0 |
| K251727 | GLAM LED Facial Mask (TB-2386F) | 2025 | 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 28 years and passes through 11 companies; a new generation was cleared every 1.4 years on median.
- 6 of the 166 ancestors have a recall of any class.
- Of its descendants, K242700 (Shenzhen Nuon Medical Equipment Co., Ltd., 2024) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K213184.
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. 2023, 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?
Red Light is intended to treat full face wrinkles
Blue Light is intended to treat mild to moderate inflammatory acne
Red + Infrared Light is intended to treat full face wrinkles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230293 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230293: TheraFace Mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230293
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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