510(k) · Cleared
ClearedSmoothcool
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeisys Medical, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 5, 2010 after a 213-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 5, 2010
- Review
- 213 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The left handpiece (560nm) of the SmoothCool is indicated for the treatment of benign pigmented lesions (including, but not limited to solar lentigines, ephilides, mottled pigmentation) and benign vascular lesions (diffuse redness). The right handpiece (700nm) is indicated for hair removal (permanent hair reduction).
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K092326 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092326: Smoothcool.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092326
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)
- Page last updated Nov 3, 2026