DeviceClearance

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)— 510(k) K231997

Substantially Equivalent

Cure 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.. Device class: 2.

Clearance details

Applicant
Cure Point Therapeutics, Inc.
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
Cheyenne, WY, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code ILY

view all

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.