510(k) Report

510(k) · Cleared

Cleared

PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500

K070287510(k) TraditionalCleared Feb 12, 200714-day reviewClass I21 CFR 872.4630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Photonic Optische Gerate GmbH & Cokg · EBA Light, Surgical Headlight

Cleared on Feb 12, 2007 as substantially equivalent to K983714 (Cogent Light Technologies, Inc., 1998) and 5 other predicates after a 14-day review. Its family tree reaches back 1 generation to 1998.

Decided
Feb 12, 2007
Review
14 days
Class
Class I
Product code
EBA
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K983714 (1998). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2005: 1 other ancestor2002: 1 other ancestor2000: 1 other ancestor1999: 2 other ancestorsK983714 · Solartec Source 270, Model # 90123 · Cogent Light Technologies, Inc. · 19981996199820002002200420062008
Other ancestors, by generation 1 generation back: 5 other ancestors K983714 · Solartec Source 270, Model # 90123 · Cogent Light Technologies, Inc. · 19980
  1. Root · 1 generation backK983714 Solartec Source 270, Model # 90123Cogent Light Technologies, Inc. · 1998
  2. This deviceK070287 PS Series with Fiber Light Guide and Headlight, Models PS200, PS250…Photonic Optische Gerate GmbH & Cokg · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983714Solartec Source 270, Model # 90123Cogent Light Technologies, Inc.1998—
0 (this device)K070287PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500Photonic Optische Gerate GmbH & Cokg2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199920
200010
200210
200510
FIG. 1 — Lineage of K070287, 1998–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 EBA? 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
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What was it cleared against? (6)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K983714Solartec Source 270, Model # 90123
Summary page 1
…4" Common Name Light source Predicate Devices Cogent/WelchAllyn Solartec Source ST270 K983714 II, FFS, 876.1500 (CL300) -M01~9 Cogent/WelchAllyn Micro Link endosc…
Cogent Light Technologies, Inc.1998—
*K001698Micro Link Endoscopic Fiber Cable, Model B1-90159
Summary page 1
…Solartec Source ST270 K983714 II, FFS, 876.1500 (CL300) -M01~9 Cogent/WelchAllyn Micro Link endoscopic K001698 II, FFS&KOD 876.1500 fiber cable II, HBI&FST, 878.4580 Isol…
Cogent Light Technologies, Inc.2000—
*K022384Xenon Fiberoptic Light Source, Model 1300 XSBP
Summary page 1
…II, FFS&KOD 876.1500 fiber cable II, HBI&FST, 878.4580 Isolux America 1300 XSBP K022384 II, HET, 884.1720 Isolux America 1125 XSB K052979 II, HBI, 878.4580…
Isolux America2002—
*K0529791125 XSB Xenon Fiber-Optic Light Source
Summary page 1
…II, HBI&FST, 878.4580 Isolux America 1300 XSBP K022384 II, HET, 884.1720 Isolux America 1125 XSB K052979 II, HBI, 878.4580 I, EAZ, 872.4630 Isolux America…
Isolux, LLC2005—
*K991572Isolux Surgical Headlight
Summary page 1
…79 II, HBI, 878.4580 I, EAZ, 872.4630 Isolux America Fiber optic surgical K991572 II, FST, 878.4580 ________ ____ ____ ___ headlight _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _…
Isolux America1999—
*K991208Endoscopic Fiberoptic Cable
Summary page 1
…________ ____ ____ ___ headlight _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ Isolux America fiberoptic cable K991208 II, HBI,878.4580 Device Description The cold light sources of the PS series consist of short arc metal-halide or xenon la…
Isolux America1999—

Also cleared against K983714: 1 other device →

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?

  • None of the 6 ancestors has a recall.
  • 1 other device also cites its predicate K983714.

How does its category compare?

All EBA devices

EBA Light, Surgical Headlight: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · EBA

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EBA

Too few EBA 510(k)s in any year since 2007 to give a median.

Recalls per year · EBA

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EBA

1in 2025

2008: 12012: 12014: 52015: 42019: 22024: 12025: 1
2007high 5 (2014) · low 0 (2007)2025

MAUDE reports naming product code EBA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—01
20090—00
20100—00
20110—10
20120—01
20130—00
20140—05
20150—04
20160—00
20170—00
20180—00
20190—02
20200—00
20210—00
20220—00
20230—00
20240—01
20250—01
20260—0—

What is it indicated for?

The AC-powered dental operating light, which can be attached via optical fibers to a surgical headlight, is a device intended to illuminate oral structures and operating areas.

Indications for use as stated in the FDA summary.

Also cleared against K983714

1 other device cites the same predicate.

  • K061622PS SeriesPhotonic Optische Gerate Gesmbh & Cokg · 2007

Recent decisions in EBA

The EBA category page

  • K923949Sylvan Dental Headlight SystemSylvan Medical Fiberoptics · 1992
  • K893458Fiberoptic Headlight SystemCuda Products Co. · 1989
  • K854646Vega Dental Operating LightAlpine Dental Equipment Co. · 1986
  • K842515Surgical HeadlightGood-Lite Co. · 1984
  • K842358IsolightPlanmeca USA, Inc. · 1984

https://510kreport.com/device/K070287 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070287: PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070287

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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