SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)— 510(k) K231997
Substantially EquivalentCure Point Therapeutics, Inc.
FDA 510(k) clearance K231997 for SIRONA 100 Therapy Laser System (OEM's Model EVANLAS), Substantially Equivalent on 2024-10-15. Applicant: Cure Point Therapeutics, Inc..
Clearance details
- Applicant
- Cure Point Therapeutics, Inc.
- Product code
- Code ILY
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cheyenne, WY, 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.