510(k) · Cleared
ClearedSolartec Source 270, Model # 90123
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cogent Light Technologies, Inc. · FFS Image, Illumination, Fiberoptic, For Endoscope
Cleared on Dec 23, 1998 after a 63-day review. The FDA summary names no predicate by number. 2 later devices descend from it.
- Decided
- Dec 23, 1998
- Review
- 63 days
- Class
- Class II
- Product code
- FFS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK983714 Solartec Source 270, Model # 90123Cogent Light Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK061622 PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007
- Descendant · cites it directly · 0 of its ownK070287 PS Series with Fiber Light Guide and Headlight, Models PS200, PS250…Photonic Optische Gerate GmbH & Cokg · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983714 | Solartec Source 270, Model # 90123 | Cogent Light Technologies, Inc. | 1998 | — |
| +1 | K061622 | PS Series | Photonic Optische Gerate Gesmbh & Cokg | 2007 | — |
| +1 | K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FFS? 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?
The FDA summary names no predicate by number.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K061622 (Photonic Optische Gerate Gesmbh & Cokg, 2007) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FFS devicesFFS Image, Illumination, Fiberoptic, For Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FFS
3in 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · FFS
74in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FFS
1in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FFS
5in 2024
MAUDE reports naming product code FFS, 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 | 3 | 74 | 1 | 12 |
| 2008 | 0 | — | 0 | 17 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 0 | — | 0 | 5 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 19 |
| 2018 | 0 | — | 0 | 19 |
| 2019 | 0 | — | 0 | 17 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 57 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 6 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SolarTec™ Source 270 System is intended for use:
1. To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlights that contain fiber bundles or single fibers for illumination
2. In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals.
3. With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983714 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983714: Solartec Source 270, Model # 90123.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983714
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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