510(k) · Cleared
ClearedOpton Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Medizinsystems GmbH · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 24, 2014 as substantially equivalent to K091497 (Eltech S.R.L, 2009) and 1 other predicate after a 134-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Oct 24, 2014
- Review
- 134 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K001179 (2000). 14 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 4 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- 3 generations backK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
- 2 generations backK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
- 1 generation backK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
- This deviceK141564 Opton ProZimmer Medizinsystems GmbH · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −4 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| −3 | K050070 | K-Laser, Models 3,4,4D,6D | Eltech S.R.L | 2005 | — |
| −2 | K070400 | LC Therapy, Model LCT-1000 | Litecure, LLC | 2007 | — |
| −1 | K091497 | K-Laser K-1200, Model 12 W | Eltech S.R.L | 2009 | — |
| 0 (this device) | K141564 | Opton Pro | Zimmer Medizinsystems GmbH | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 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 ILY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K091497 | K-Laser K-1200, Model 12 WSummary page 5…4717 Adams Road. P.O. Box 489 31100 Trevisio, Italy Hixson, Tennessee 37343-0489 510(k) number K091497 K040662 c.) Device Description OptonPro is a topical heat lamp with laser light. It emits energy… | 2009 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 5…ox 489 31100 Trevisio, Italy Hixson, Tennessee 37343-0489 510(k) number K091497 K040662 c.) Device Description OptonPro is a topical heat lamp with laser light. It emits energy in the infrared spectrum to provide to… | 2004 |
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?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 14 ancestors has a recall.
- 2 other devices also cite its predicate K091497.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
• temporary relief of minor muscle and joint aches, pains and stiffness
• temporary relief of muscle spasm
• temporary relief of minor pain and stiffness associated with arthritis
• promoting relaxation of the muscle tissue
• temporary increase in local blood circulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141564: Opton Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141564
Report an extraction error
Are you the manufacturer?
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