510(k) · Cleared
ClearedINTRAGen
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeisys Medical, Inc. · OUH Skin Resurfacing Rf Applicator
Cleared on Jun 4, 2015 as substantially equivalent to K053365 (Thermage, Inc., 2005) after a 247-day review. Its family tree reaches back 1 generation to 2005.
- Decided
- Jun 4, 2015
- Review
- 247 days
- Class
- Class II
- Product code
- OUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053365 (2005). No later device cites it as a predicate yet.
- Root · 1 generation backK053365 Modification to Thermage Thermacool SystemThermage, Inc. · 2005
- This deviceK142833 INTRAGenJeisys Medical, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053365 | Modification to Thermage Thermacool System | Thermage, Inc. | 2005 | — |
| 0 (this device) | K142833 | INTRAGen | Jeisys Medical, Inc. | 2015 | — |
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 OUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K053365 | Modification to Thermage Thermacool SystemSummary page 5…II 4. Identification of Predicate Device(s) The identified predicate devices within this submission are shown as follow; • 510(k) Number: K053365 • Applicant: Thermage Inc. • Common Name: Electrosurgical Unit • Device Name:… | 2005 |
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?
- Its one ancestor has no recall.
- 5 other devices also cite its predicate K053365.
How does its category compare?
All OUH devicesOUH Skin Resurfacing Rf Applicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · OUH
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · OUH
Too few OUH 510(k)s in any year since 2007 to give a median.
Recalls per year · OUH
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OUH
3in 2025
MAUDE reports naming product code OUH, 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 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 1 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The INTRAgen is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142833: INTRAGen.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142833
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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