510(k) · Cleared
ClearedSonilase Light Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biorenew Labs, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Feb 5, 2014 as substantially equivalent to K110735 (Pharos Life Corporation, 2011) after a 168-day review. Its family tree reaches back 1 generation to 2011. 1 later device descends from it.
- Decided
- Feb 5, 2014
- Review
- 168 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K110735 (2011). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK110735 Tanda Max Otc SystemPharos Life Corporation · 2011
- This deviceK132613 Sonilase Light Therapy DeviceBiorenew Labs, LLC · 2014
- Descendant · cites it directly · 0 of its ownK171647 BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company, Ltd. · 2017
Most influential descendants
Showing 1 of 1 · See all- K171647BeneLife Premium Facial Treatment Pack, Model: QZ0701AInfinitus (China) Company, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K110735 | Tanda Max Otc System | Pharos Life Corporation | 2011 | — |
| 0 (this device) | K132613 | Sonilase Light Therapy Device | Biorenew Labs, LLC | 2014 | — |
| +1 | K171647 | BeneLife Premium Facial Treatment Pack, Model: QZ0701A | Infinitus (China) Company, Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 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 |
|---|---|---|---|
| * | K110735 | Tanda Max Otc SystemSummary page 2…device is OTC. 5. Predicate Device: This device is substantially equivalent to the following predicate device, which is currently in safe and effective commerce: 1. K1 10735 - Tanda Max OTC System (Pharos Life Corporation) Predicate Chart… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171647 | BeneLife Premium Facial Treatment Pack, Model: QZ0701A | 2017 | 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?
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. 2014, 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 SonilaseTM Light Device Red is used to treat periorbital wrinkles and fine lines around the eyes (i.e., crow's feet).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132613 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132613: Sonilase Light Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132613
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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