510(k) · Cleared
ClearedColdlightsource PL3000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fiber Imaging Technologies, Inc. · FCW Light Source, Fiberoptic, Routine
Cleared on Nov 5, 1999 as substantially equivalent to K890716 (Luxtec Corp., 1989) after a 35-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Nov 5, 1999
- Review
- 35 days
- Class
- Class II
- Product code
- FCW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K890716 (1989). No later device cites it as a predicate yet.
- Root · 1 generation backK890716 Luxtec Aco Series 4000 Light SourceLuxtec Corp. · 1989
- This deviceK993300 Coldlightsource PL3000Fiber Imaging Technologies, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890716 | Luxtec Aco Series 4000 Light Source | Luxtec Corp. | 1989 | — |
| 0 (this device) | K993300 | Coldlightsource PL3000 | Fiber Imaging Technologies, Inc. | 1999 | — |
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 |
|---|---|---|---|
| * | K890716 | Luxtec Aco Series 4000 Light SourceSummary page 1…de Name of the Device: Coldsource PL3000 Common Name: Light source Class1f1catlon Name: Endoscope and Accessorles Product code: KOG (per 876.1500) 3. Predicate Device: K890716, Luxtec Model 3150 Light Source 4. Description of the Device: The Photonics Coldlightsource PL3000 is a lightsource for fiberopt… | 1989 |
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.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Photonics Coldlightsource PL3000 is indicated for use to provide illumination through light-conducting devices such as fiberoptic cables.
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/K993300 · printed Nov 5, 2026
Cite this page
510(k) Report. “K993300: Coldlightsource PL3000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993300
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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