510(k) K231997

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) by Cure Point Therapeutics, Inc. — Product Code ILY

K231997 is an FDA 510(k) premarket notification submitted by Cure Point Therapeutics, Inc. for the device "SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)". The FDA issued a decision of Substantially Equivalent on October 15, 2024. The device falls under product code ILY (Lamp, Infrared, Therapeutic Heating), a Class II device regulated under 21 CFR 890.5500.