510(k) · Cleared
ClearedLUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 15, 2023 as substantially equivalent to K214103 (Harpar Grace International, 2022) after a 57-day review. Its family tree reaches back 17 generations to 1995. 10 later devices descend from it.
- Decided
- Mar 15, 2023
- Review
- 57 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 114 ancestors in all, the oldest K800617 (1980). 10 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 2 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 1 generation backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- This deviceK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- Descendant · 2 generations on · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK261496 LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited · 2026
- Descendant · 3 generations on · 0 of its ownK260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 11 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 10 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 9 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 8 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 7 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 6 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 5 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 4 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 3 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 2 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 1 generation backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- This deviceK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · cites it directly9descendants
- K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · 2 generations on2descendants
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 2 generations on0descendants
- K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading Limited · 2026 · 2 generations on0descendants
- K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −11 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −10 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −9 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −8 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −7 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −6 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −5 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −4 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −3 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −2 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| −1 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| 0 (this device) | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 | — |
| +2 | K251588 | LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) | Shenzhen Fittop Health Technology Co., Ltd. | 2025 | — |
| +2 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +2 | K261496 | LED Light Therapy Masks (PE748, PE749, PE756) | Duplex International Trading Limited | 2026 | — |
| +3 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026 | — |
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 |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 6 | 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? (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 |
|---|---|---|---|
| * | K214103 | Shani Darden LED light therapy maskSummary page 5…D light therapy mask Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over- The Counter Wrinkle Reduction (OHS) 510(k) Number: K214103 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II 5. Dev… | 2022 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | 2023 | 9 |
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 12 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 114 ancestors have a recall of any class.
- Of its descendants, K230042 (Light Tree Ventures Europe B.V., 2023) has gone furthest, with 9 descendants of its own.
- 5 other devices also cite its predicate K214103.
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?
The LUSTRE ClearSkin Renew Pro Facewear 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 LUSTRE ClearSkin Renew Pro Facewear 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/K230124 · printed Nov 5, 2026
Cite this page
510(k) Report. “K230124: LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K230124
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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