510(k) · Cleared
ClearedShani Darden LED light therapy mask
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Harpar Grace International · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Mar 22, 2022 as substantially equivalent to K213184 (Mz Skin, 2021) after an 83-day review. Its family tree reaches back 16 generations to 1995. 19 later devices descend from it.
- Decided
- Mar 22, 2022
- Review
- 83 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 113 ancestors in all, the oldest K800617 (1980). 19 later devices descend from it, 6 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 deviceK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- Descendant · cites it directly · 10 of its ownK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- Descendant · 2 generations on · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 7 of its ownK221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022
- Descendant · cites it directly · 3 of its ownK242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology 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 deviceK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023 · cites it directly10descendants
- K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · 2 generations on9descendants
- K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022 · cites it directly7descendants
- K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly3descendants
- K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · 2 generations on2descendants
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) | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| +1 | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | Light Tree Ventures Europe B.V. | 2023 | — |
| +2 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022 | — |
| +1 | K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F… | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 5 | 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 OLP? 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 OLP device
- #1 K213184 MZ Skin LightMAX Supercharged LED Mask 2.0score 18.6 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 6…-counter device intended to emit energy in the red and near infra-red spectrum and is intended for the use in the treatment of full-face wrinkles. 5.3. Predicate device K213184 MZ Skin LightMAX Supercharged LED Mask 2.0 K214103… | 2021 |
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | 2023 | 10 |
| K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | 2022 | 7 |
| K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) | 2025 | 3 |
| K241933 | HIGHERDOSE Red and Infrared Light Mask (MK66-L) | 2024 | 1 |
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | 2026 | 0 |
| K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | 2026 | 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 27 years and passes through 11 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 113 ancestors have a recall of any class.
- Of its descendants, K230124 (Light Tree Ventures Europe B.V., 2023) has gone furthest, with 10 descendants of its own.
- 3 other devices also cite its predicate K213184.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, 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 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face.
The Shani Darden LED light therapy mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K214103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K214103: Shani Darden LED light therapy mask.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K214103
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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