Device Class Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)
Product Code Over-The-Counter Powered Light Based Laser For Acne (OLP) (1) Powered Light Based Non-Laser Surgical Instrument With Thermal Effect (ONF) (1)