510(k) · Cleared
ClearedClearwave Phototherapy System for Acne, Model: CWST2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verilux · ONE Powered Light Based Non-Laser Surgical Instrument
Cleared on Sep 3, 2010 as substantially equivalent to K080591 (Pharos Life Corporation, 2008) after a 504-day review. Its family tree reaches back 3 generations to 1998.
- Decided
- Sep 3, 2010
- Review
- 504 days
- Class
- Class II
- Product code
- ONE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K982082 (1998). 7 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK091125 Clearwave Phototherapy System for Acne, Model: CWST2Verilux · 2010
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) | K091125 | Clearwave Phototherapy System for Acne, Model: CWST2 | Verilux | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 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 ONE? 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 ONE device
- #1 K250224 handLITE (TN19S)score 13.4 · 15 generations · no Class I recall
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…CFR 878.48 10, Product Code GEX, Panel 79) Substantial Equivalence: The ClearWave® Phototherapy System for Acne is substantially equivalent to the Tanda Skincare System (K08059 1). The intended use and technological characteristics of the ClearWave® Phototherapy System for Acne are similar to the intended u… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 12 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- None of the 7 ancestors has a recall.
- 6 other devices also cite its predicate K080591.
How does its category compare?
All ONE devicesONE Powered Light Based Non-Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ONE
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONE
376in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONE
No recall names ONE since 2007.
Adverse event reports per year · ONE
1in 2018
MAUDE reports naming product code ONE, 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 | 0 | — | 0 | 0 |
| 2010 | 4 | 376 | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to
treat mild to moderate inflammatory acne.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091125 · printed Nov 6, 2026
Cite this page
510(k) Report. “K091125: Clearwave Phototherapy System for Acne, Model: CWST2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K091125
Report an extraction error
Are you the manufacturer?
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