510(k) · Cleared
ClearedLuna 4 plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foreo, Inc. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 20, 2024 as substantially equivalent to K162652 (Li-Tek Electronic Technology Corporation, 2017) and 2 other predicates after a 120-day review. Its family tree reaches back 16 generations to 1995. 5 later devices descend from it.
- Decided
- Aug 20, 2024
- Review
- 120 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 164 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 2 generations backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- 1 generation backK212155 TheraFace LEDTheragun, Inc. · 2021
- This deviceK241102 Luna 4 plusForeo, Inc. · 2024
- Descendant · cites it directly · 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 · 1 of its ownK253712 LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062…Shenzhen Rainbow Technology 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
- Descendant · 3 generations on · 0 of its ownK261407 XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342…Dongguan Miqiang Technology Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK250880 Led Light Mask (A093)Foshan Guangyu Weilai 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 backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 6 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 5 generations backK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
- 4 generations backK111286 Quasar CalypsoSilver Bay, LLC · 2012
- 3 generations backK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- 2 generations backK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- 1 generation backK212155 TheraFace LEDTheragun, Inc. · 2021
- This deviceK241102 Luna 4 plusForeo, Inc. · 2024
Most influential descendants
Showing 5 of 5 · See all- K243423LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J…Shenzhen Rainbow Technology Co., Ltd. · 2025 · cites it directly3descendants
- 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 · 2 generations on1descendant
- K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd. · 2026 · cites it directly0descendants
- K261407XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422…Dongguan Miqiang Technology Co., Ltd. · 2026 · 3 generations on0descendants
- K250880Led Light Mask (A093)Foshan Guangyu Weilai Medical Equipment Co., Ltd. · 2025 · 2 generations on0descendants
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 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −6 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −5 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
| −4 | K111286 | Quasar Calypso | Silver Bay, LLC | 2012 | — |
| −3 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| −2 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| −1 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
| 0 (this device) | K241102 | Luna 4 plus | Foreo, Inc. | 2024 | — |
| +1 | K243423 | LED Light Therapy Mask (Model (s): RB-008, RB-030, RB-081, RB-008G, RB-008GB… | Shenzhen Rainbow Technology Co., Ltd. | 2025 | — |
| +2 | K253712 | LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072… | Shenzhen Rainbow Technology Co., Ltd. | 2026 | — |
| +1 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS… | Kam Yuen Plastic Products, Ltd. | 2026 | — |
| +3 | K261407 | XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368… | Dongguan Miqiang Technology Co., Ltd. | 2026 | — |
| +2 | K250880 | Led Light Mask (A093) | Foshan Guangyu Weilai 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 | 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 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K162652 | Smart Photon Micro-current Device, Model: EP-300Summary page 5…OHS, NFO Predicate Device: The legally marketed predicate devices to which FOREO, Inc. is claiming equivalence for over-the-counter use: 510(k) Number: K162652 Manufacturer: Guangzhou LETA Testing Technology Co., Ltd Product Code: OHS, NFO, OLP 510(k) Number: K… | 2017 |
| * | K212155 | TheraFace LEDSummary page 5…ct Code: OHS, NFO, OLP 510(k) Number: K201906 Manufacturer: Carol Cole Company dba NuFACE Product Code: NFO 510(k) Number: K212155 Manufacturer: Theragun, Inc Product Code: OHS, OLP, IRO Device Description: Luna 4 plus has mu… | 2021 |
| * | K201906 | Trinity ELE Plus and Trinity ELE Plus ProSummary page 5…unter use: 510(k) Number: K162652 Manufacturer: Guangzhou LETA Testing Technology Co., Ltd Product Code: OHS, NFO, OLP 510(k) Number: K201906 Manufacturer: Carol Cole Company dba NuFACE Product Code: NFO 510(k) Number: K212155 Manufacturer:… | 2021 |
What descends from it? (5)
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 12 companies; a new generation was cleared every 1.4 years on median.
- 4 of the 164 ancestors have a recall of any class.
- Of its descendants, K243423 (Shenzhen Rainbow Technology Co., Ltd., 2025) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K162652.
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. 2024, 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?
Luna 4 plus is a Near-Infrared Heated Cleansing Device With Red LED/NIR light & Microcurrent Massage.
Microcurrent: indicated for facial stimulation
RED+NIR: indicated to treat periorbital wrinkles
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241102 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241102: Luna 4 plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241102
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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