Medical Device Manufacturer · CN , Guangzhou

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

3 submissions · 3 cleared · Since 2023

Recent clearances: LED Light Therapy Masks (LumiLips FAC07NA), LED light therapy mask (FM-01, FM-02, FM-03)

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Guangdong Newdermo Biotech Co., Ltd. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Jun 18, 2026

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

General & Plastic Surgery · 87d

Cleared Mar 23, 2026

LED Light Therapy Masks (LumiLips FAC07NA)

General & Plastic Surgery · 59d

Cleared Feb 23, 2023

LED light therapy mask (FM-01, FM-02, FM-03)

General & Plastic Surgery · 90d