K231997
- 510(k) number
- K231997
- Device name
- SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
- Applicant
- Cure Point Therapeutics, Inc. WY · US
- Product code
- ILY — Lamp, Infrared, Therapeutic Heating
- Decision date
- 2024-10-15
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K231997
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.