K243555
Trade/Device Name: LED light therapy mask
Model Number: E49B
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OLP, OHS
Dated: November 15, 2024
Received: November 18, 2024
Intended Use :
Mode 1 (Red +Infrared light): treatment of full face wrinkles.
Mode 2 (Blue light):Treatment of mild to moderate inflammatory acne.
Mode 3 (Mixed light): Treatment of mild to moderate inflammatory acne.
Intended Location of Use: Face
Material: Medical-grade silicone
Battery capacity- 2000mAh polymer lithium battery
Input: AC100-240V 50/60HZ
Output: DC5V 1A
Power: 5w
Facial lamp beads: 108 pcs
3 levels of intensity
Charging interface: Micro USB
Charging time: 40 minutes
Available time: 120 minutes
Wavelength-
Blue: 415nm,
Red: 630nm,
NIR: 850nm
Mixed: 415nm+630nm+850nm