510(k) · Cleared
ClearedWeberneedle Basic Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Weber Medical GmbH · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Aug 11, 2008 as substantially equivalent to K033923 (Thor Intl., 2004) and 1 other predicate after a 256-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Aug 11, 2008
- Review
- 256 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033923 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033923 TH0R Ddii IR Lamp SystemThor Intl. · 2004
- This deviceK073352 Weberneedle Basic LaserWeber Medical GmbH · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033923 | TH0R Ddii IR Lamp System | Thor Intl. | 2004 | — |
| 0 (this device) | K073352 | Weberneedle Basic Laser | Weber Medical GmbH | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 1…evices to the weberneedlefbasic laser and the weberneedlefbasic 'compact edition" laser include, but are not limited to, the Thor Int. DDII Laser System (K033923) and the Chattanooga Group Vectra Ganisys Laser System (K040662). These weber medical GmbH HRB 101161 H… | 2004 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 1…'compact edition" laser include, but are not limited to, the Thor Int. DDII Laser System (K033923) and the Chattanooga Group Vectra Ganisys Laser System (K040662). These weber medical GmbH HRB 101161 HOL RegistergerichtHolzminden Bankverbindung: Coonmerzbank Holz… | 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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K033923.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The weberneedledbasic laser is indicated to provide
topical heating for the following:
• temporary increase of local blood circulation.
* temporary relief of minor muscle and joint aches, pains, and stiffness.
* temporary relaxation of muscles.
* temporary relief of muscle spasms.
* temporary relief of minor pain and stiffness associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073352: Weberneedle Basic Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073352
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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