510(k) · Cleared
ClearedTanda Mini Skincare System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Syneron Beauty · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Apr 2, 2013 as substantially equivalent to K080591 (Pharos Life Corporation, 2008) after a 95-day review. Its family tree reaches back 3 generations to 1998. 76 later devices descend from it.
- Decided
- Apr 2, 2013
- Review
- 95 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982082 (1998). 7 ancestors in all. 76 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK982082 Handisol Wound HealingNational Biological Corp. · 1998
- 2 generations backK043377 ZENOTyrell, Inc. · 2005
- 1 generation backK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
- This deviceK124042 Tanda Mini Skincare SystemSyneron Beauty · 2013
- Descendant · cites it directly · 50 of its ownK160691 Acne Light Therapy WandZuko, Inc. · 2016
- Descendant · cites it directly · 46 of its ownK153081 Clear Bi-LightMichael Todd, LP · 2016
- Descendant · 2 generations on · 39 of its ownK210948 Omnilux CLEARGlobalmed Technologies · 2021
- Descendant · 3 generations on · 35 of its ownK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- Descendant · 2 generations on · 35 of its ownK180447 reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
Showing 5 of 76 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 76 · See all- K160691Acne Light Therapy WandZuko, Inc. · 2016 · cites it directly50descendants
- K153081Clear Bi-LightMichael Todd, LP · 2016 · cites it directly46descendants
- K210948Omnilux CLEARGlobalmed Technologies · 2021 · 2 generations on39descendants
- K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021 · 3 generations on35descendants
- K180447reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| −2 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| −1 | K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | 2008 | — |
| 0 (this device) | K124042 | Tanda Mini Skincare System | Syneron Beauty | 2013 | — |
| +1 | K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016 | — |
| +1 | K153081 | Clear Bi-Light | Michael Todd, LP | 2016 | — |
| +2 | K210948 | Omnilux CLEAR | Globalmed Technologies | 2021 | — |
| +3 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| +2 | K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 7 | 0 |
| 2025 | 26 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K080591 | Tanda Skincare System, Model: PtscsSummary page 1…General and Plastic Surgery Devices Panel Regulation Number: 21 C.F.R 878.48 10 Product Code: OLP Predicate Device Syneron Beauty Inc.'s Tanda Skincare System (K080591) Intended Use / Indications for Use The Tanda Mini Skincare System is generally indicated to treat dermato… | 2008 |
What descends from it? (76)
See all 767 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160691 | Acne Light Therapy Wand | 2016 | 50 |
| K153081 | Clear Bi-Light | 2016 | 46 |
| K180320 | dpl IIa Panel | 2018 | 14 |
| K161941 | Pulsaderm Acne Device | 2016 | 4 |
| K161434 | Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | 2017 | 3 |
| K152889 | Sonilase Blue, Sonilase Blue-Clean, Sonilase Blue-UV Clean Plus | 2015 | 3 |
| K162371 | Pulsaderm ACE-All Blue | 2016 | 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 15 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K160691 (Zuko, Inc., 2016) has gone furthest, with 50 descendants of its own.
- 6 other devices also cite its predicate K080591.
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. 2013, 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 Tanda Mini Skincare System is generally indicated to treat dermatological conditions. Specifically, Blue light modules are indicated to treat mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K124042 · printed Nov 6, 2026
Cite this page
510(k) Report. “K124042: Tanda Mini Skincare System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K124042
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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