Medical Device Manufacturer · CN , Guangzhou

Guangdong Newdermo Biotech Co., Ltd. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2023

Recent clearances: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)), LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K), LED Light Therapy Masks (LumiLips FAC07NA)

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Guangdong Newdermo Biotech Co., Ltd. Neurology ✕

1 devices

1-1 of 1

Cleared Sep 16, 2026

LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

Neurology · 142d