510(k) · Cleared
ClearedMZ Skin LightMAX Supercharged LED Mask 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mz Skin · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Nov 23, 2021 as substantially equivalent to K210948 (Globalmed Technologies, 2021) and 1 other predicate after a 55-day review. Its family tree reaches back 15 generations to 1995. 35 later devices descend from it.
- Decided
- Nov 23, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 112 ancestors in all, the oldest K800617 (1980). 35 later devices descend from it, 4 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- This deviceK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- Descendant · cites it directly · 19 of its ownK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- Descendant · cites it directly · 16 of its ownK230293 TheraFace MaskTherabody, Inc. · 2023
- Descendant · 2 generations on · 10 of its ownK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- Descendant · 3 generations on · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- Descendant · 2 generations on · 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
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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 5 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 4 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 3 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 2 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 1 generation backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- This deviceK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K214103Shani Darden LED light therapy maskHarpar Grace International · 2022 · cites it directly19descendants
- K230293TheraFace MaskTherabody, Inc. · 2023 · cites it directly16descendants
- K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023 · 2 generations on10descendants
- K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · 3 generations on9descendants
- K221775LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)Light Tree Ventures Europe B.V. · 2022 · 2 generations on7descendants
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 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −5 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −4 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −3 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −2 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −1 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| 0 (this device) | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| +1 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| +1 | K230293 | TheraFace Mask | Therabody, Inc. | 2023 | — |
| +2 | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | Light Tree Ventures Europe B.V. | 2023 | — |
| +3 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 | — |
| +2 | K221775 | LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) | Light Tree Ventures Europe B.V. | 2022 | — |
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 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 18 | 0 |
| 2026 | 6 | 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 K214103 Shani Darden LED light therapy maskscore 25.5 · 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 |
|---|---|---|---|
| * | K210948 | Omnilux CLEARSummary page 6…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 devices Omnilux CLEAR (K210948) Globalmed Technologies faceLITE (K191629) iSMART Marketing Svcs Ltd K213184… | 2021 |
| * | K191629 | faceLITESummary page 6…d is intended for the use in the treatment of full-face wrinkles. 5.3. Predicate devices Omnilux CLEAR (K210948) Globalmed Technologies faceLITE (K191629) iSMART Marketing Svcs Ltd K213184… | 2019 |
What descends from it? (35)
See all 354 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 10 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 112 ancestors have a recall of any class.
- Of its descendants, K214103 (Harpar Grace International, 2022) has gone furthest, with 19 descendants of its own.
- 2 other devices also cite its predicate K210948.
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. 2021, 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 MZ Skin LightMAX Supercharged LED Mask 2.0 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 MZ Skin LightMAX Supercharged LED Mask 2.0 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K213184 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213184: MZ Skin LightMAX Supercharged LED Mask 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213184
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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