510(k) · Cleared
ClearedLed Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunoptic Technologies, LLC · FCW Light Source, Fiberoptic, Routine
Cleared on Mar 18, 2010 as substantially equivalent to K082813 (Stryker Corp., 2008) after a 98-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Mar 18, 2010
- Review
- 98 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K961971 (1996). 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK961971 Q-5000Stryker Endoscopy · 1996
- 1 generation backK082813 Stryker Led LightsourceStryker Corp. · 2008 · Recalled
- This deviceK093792 Led Light SourceSunoptic Technologies, LLC · 2010
- Descendant · cites it directly · 3 of its ownK102167 LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK123359 OVS1 Video SystemOlive Medical Corp. · 2012
- Descendant · 2 generations on · 1 of its ownK121724 Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012
- Descendant · cites it directly · 1 of its ownK103813 SOPRO 281Sopro · 2011
- Descendant · 2 generations on · 0 of its ownK152513 8X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K102167LO-50 Led Light SourceFiberoptics Technology, Inc. · 2010 · cites it directly3descendants
- K123359OVS1 Video SystemOlive Medical Corp. · 2012 · cites it directly1descendant
- K121724Endolight Led 1.1 Endolightled 1.2Richard Wolf Medical Instruments Corp. · 2012 · 2 generations on1descendant
- K103813SOPRO 281Sopro · 2011 · cites it directly1descendant
- K1525138X-10-XXXX Camera SystemSanta Barbara Imaging Systems · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961971 | Q-5000 | Stryker Endoscopy | 1996 | — |
| −1 | K082813 | Stryker Led Lightsource | Stryker Corp. | 2008 | 1 |
| 0 (this device) | K093792 | Led Light Source | Sunoptic Technologies, LLC | 2010 | — |
| +1 | K102167 | LO-50 Led Light Source | Fiberoptics Technology, Inc. | 2010 | — |
| +1 | K123359 | OVS1 Video System | Olive Medical Corp. | 2012 | — |
| +2 | K121724 | Endolight Led 1.1 Endolightled 1.2 | Richard Wolf Medical Instruments Corp. | 2012 | — |
| +1 | K103813 | SOPRO 281 | Sopro | 2011 | — |
| +2 | K152513 | 8X-10-XXXX Camera System | Santa Barbara Imaging Systems | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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 FCW? 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 |
|---|---|---|---|
| * | K082813 | Stryker Led LightsourceSummary page 1…ight Source is substantially equivalent in terms of safety and effectiveness to currently marketed devices including the predicate device Stryker L9000 LED Light Source (K08281 3). Substantial Equivalence The technological differences between the LED Light Source (LLS-050) and the Stryker LED Light Source (… | 2008 |
What descends from it? (6)
4 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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K102167 (Fiberoptics Technology, Inc., 2010) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K082813.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 3 |
| 2008 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endloscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093792: Led Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093792
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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