510(k) · Cleared
ClearedStrialite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Centre Light Solutions, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Feb 24, 2016 as substantially equivalent to K013748 (Candela Corp., 2002) after a 281-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Feb 24, 2016
- Review
- 281 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904627 (1991). 33 ancestors in all, the oldest K882160 (1988). No later device cites it as a predicate yet.
- Root · 5 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 4 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 3 generations backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- 2 generations backK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- 1 generation backK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
- This deviceK151337 StrialiteCentre Light Solutions, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −4 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −3 | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| −2 | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| −1 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| 0 (this device) | K151337 | Strialite | Centre Light Solutions, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 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 |
|---|---|---|---|
| * | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam)Summary page 4…: Class II Classification Panel: General and Plastic Surgery 5. Legally Marketed Predicate Device(s) Candela V Beam Pulse Dye Laser System, K013748 Page 5-1… | 2002 |
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 25 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 33 ancestors has a recall.
- 3 other devices also cite its predicate K013748.
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. 2016, 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?
Strialite is an over-the-counter device indicated for use in the temporary reduction of redness in striae rubra (red stretch marks). Strialite does not remove the stretch marks but may improve their appearance
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151337 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151337: Strialite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151337
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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