510(k) · Cleared
ClearedTanda Max Otc System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharos Life Corporation · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Aug 3, 2011 after a 140-day review. The FDA summary names its predicate without a number. 84 later devices descend from it.
- Decided
- Aug 3, 2011
- Review
- 140 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 0
84 later devices descend from it, 3 citing it directly.
- This deviceK110735 Tanda Max Otc SystemPharos Life Corporation · 2011
- Descendant · cites it directly · 81 of its ownK141308 Nutra Light RedNutra Luxe MD, LLC · 2014
- Descendant · 2 generations on · 75 of its ownK162098 LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017
- Descendant · 3 generations on · 58 of its ownK171821 2 Face / Face EvolutionHeat IN A Click · 2018
- Descendant · 3 generations on · 46 of its ownK192295 PDT-FaceBeijing Adss Development Co., Ltd. · 2020
- Descendant · 4 generations on · 42 of its ownK212155 TheraFace LEDTheragun, Inc. · 2021
Showing 5 of 84 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 84 · See all- K141308Nutra Light RedNutra Luxe MD, LLC · 2014 · cites it directly81descendants
- K162098LED Phototherapy DeviceLi-Tek Electronic Technology Corporation · 2017 · 2 generations on75descendants
- K1718212 Face / Face EvolutionHeat IN A Click · 2018 · 3 generations on58descendants
- K192295PDT-FaceBeijing Adss Development Co., Ltd. · 2020 · 3 generations on46descendants
- K212155TheraFace LEDTheragun, Inc. · 2021 · 4 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110735 | Tanda Max Otc System | Pharos Life Corporation | 2011 | — |
| +1 | K141308 | Nutra Light Red | Nutra Luxe MD, LLC | 2014 | — |
| +2 | K162098 | LED Phototherapy Device | Li-Tek Electronic Technology Corporation | 2017 | — |
| +3 | K171821 | 2 Face / Face Evolution | Heat IN A Click | 2018 | — |
| +3 | K192295 | PDT-Face | Beijing Adss Development Co., Ltd. | 2020 | — |
| +4 | K212155 | TheraFace LED | Theragun, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 6 | 0 |
| 2024 | 11 | 0 |
| 2025 | 33 | 0 |
| 2026 | 16 | 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? (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 |
|---|---|---|---|
| * | — | Thinda Max System Named without a submission number | |
| * | — | Anti-wrinkle Light Named without a submission number |
What descends from it? (84)
See all 843 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?
- Of its descendants, K141308 (Nutra Luxe MD, LLC, 2014) has gone furthest, with 81 descendants of its own.
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. 2011, 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?
Thinda Max OTC is intended for the treatment of wrinkles, rhytides, and fine lines in the periorbital region.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110735: Tanda Max Otc System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110735
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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