Guangdong Newdermo Biotech Co., Ltd. is one of 2114 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Guangdong Newdermo Biotech Co., Ltd. - FDA 510(k) Cleared Devices
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
Guangdong Newdermo Biotech Co., Ltd. has 4 FDA 510(k) cleared medical devices. Based in Guangzhou, CN.
Latest FDA clearance: Sep 2026. Active since 2023. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Guangdong Newdermo Biotech Co., Ltd. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Guangdong Newdermo Biotech Co., Ltd.
4 devices
Cleared
Sep 16, 2026
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
Neurology
142d
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