Cleared Traditional

SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

K231997 · Cure Point Therapeutics, Inc. · General & Plastic Surgery

Oct 2024

Decision

468d

Days

Class 2

Risk

About This 510(k) Submission

K231997 is an FDA 510(k) clearance for the SIRONA 100 Therapy Laser System (OEM's Model EVANLAS), 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 review panel. Regulated under 21 CFR 890.5500.

Submission Details

510(k) Number	K231997 FDA.gov
FDA Decision	Cleared 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