THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE— 510(k) K070024
Substantially EquivalentThor International
FDA 510(k) clearance K070024 for THOR VR SINGLE DIODE LASER TREATMENT PROBE, MODEL 200 MW SINGLE VR DIODE PROBE, Substantially Equivalent on 2007-05-16. Applicant: Thor International. Device class: 2.
Clearance details
- Applicant
- Thor International
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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Adverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.