510(k) · Cleared
ClearedEasysuite Surgical Light Control (Eslc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Image Stream Medical, Inc. · FTA Light, Surgical, Accessories
Cleared on Nov 23, 2010 as substantially equivalent to K081698 (Image Stream Medical, Inc., 2008) after a 57-day review. Its family tree reaches back 3 generations to 2004. 2 later devices descend from it.
- Decided
- Nov 23, 2010
- Review
- 57 days
- Class
- Class II
- Product code
- FTA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041912 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK041912 SCB/Valleylab Force FX Interface UnitKARL STORZ Endoscopy-America, Inc. · 2004
- 2 generations backK051505 SCB/Steris or-Light Interface BoxKARL STORZ Endoscopy-America, Inc. · 2005
- 1 generation backK081698 Mainstream or Surgical Light Control (MSLC)Image Stream Medical, Inc. · 2008
- This deviceK102791 Easysuite Surgical Light Control (Eslc)Image Stream Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK133413 Idss SLCBlack Diamond Video · 2014
- Descendant · cites it directly · 0 of its ownK112133 Oasys Surgical Light ControllerOasys Healthcare · 2012
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 |
|---|---|---|---|---|---|
| −3 | K041912 | SCB/Valleylab Force FX Interface Unit | KARL STORZ Endoscopy-America, Inc. | 2004 | — |
| −2 | K051505 | SCB/Steris or-Light Interface Box | KARL STORZ Endoscopy-America, Inc. | 2005 | — |
| −1 | K081698 | Mainstream or Surgical Light Control (MSLC) | Image Stream Medical, Inc. | 2008 | — |
| 0 (this device) | K102791 | Easysuite Surgical Light Control (Eslc) | Image Stream Medical, Inc. | 2010 | — |
| +1 | K133413 | Idss SLC | Black Diamond Video | 2014 | — |
| +1 | K112133 | Oasys Surgical Light Controller | Oasys Healthcare | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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 FTA? 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 |
|---|---|---|---|
| * | K081698 | Mainstream or Surgical Light Control (MSLC)Summary page 1…Product Code: FTA Predicate MainStreamaTM OR Surgical Light Control (MSLC), which was cleared to Predicae market in 5 10(k) # K08 1698. The EasySuiteTM Surgical Light Control (ESLC) is an optional function in the EasySUite TM… | 2008 |
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?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K133413 (Black Diamond Video, 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FTA devicesFTA Light, Surgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FTA
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · FTA
61in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTA
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTA
19in 2025
MAUDE reports naming product code FTA, 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 | — | 2 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 18 |
| 2014 | 3 | 61 | 0 | 7 |
| 2015 | 1 | — | 0 | 15 |
| 2016 | 0 | — | 0 | 15 |
| 2017 | 0 | — | 1 | 22 |
| 2018 | 0 | — | 0 | 21 |
| 2019 | 0 | — | 0 | 20 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 0 | 14 |
| 2023 | 0 | — | 0 | 105 |
| 2024 | 0 | — | 0 | 29 |
| 2025 | 0 | — | 0 | 19 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
EasySuite TMSurgical Light Control (ESLC) allows the control of surgical lighting during a surgical procedure from the EasySuite TMtouch panel user interface.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102791 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102791: Easysuite Surgical Light Control (Eslc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102791
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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