PAINACEA MODEL XR8 INFRARED HEAT LAMP— 510(k) K051046
Substantially EquivalentAtlantis Luminescent Products, LLC
FDA 510(k) clearance K051046 for PAINACEA MODEL XR8 INFRARED HEAT LAMP, Substantially Equivalent on 2005-05-10. Applicant: Atlantis Luminescent Products, LLC.
Clearance details
- Applicant
- Atlantis Luminescent Products, LLC
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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.