K231997 is an FDA 510(k) clearance for the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS). This device is classified as a Lamp, Infrared, Therapeutic Heating (Class II - Special Controls, product code ILY).
Submitted by Cure Point Therapeutics, Inc. (Cheyenne, US). The FDA issued a Cleared decision on October 15, 2024, 468 days after receiving the submission on July 5, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 890.5500.
| 510(k) Number | K231997 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 05, 2023 |
| Decision Date | October 15, 2024 |
| Days to Decision | 468 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | ILY - Lamp, Infrared, Therapeutic Heating |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5500 |