# Guangdong Newdermo Biotech Co., Ltd.

- Location (FDA's records): Guangzhou, CN
- FDA decisions: 5 (2023–2026): 5 510(k) clearances
- Product codes: OHS (4), NFO (1)
- 510(k) review time since 2016: median 90 days, against 88 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 15 (0 its own); citations of its devices by later devices: 13 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Harpar Grace International: 2 (https://510kreport.com/company/harpar-grace-international)
- Led Technologies, Inc.: 1 (https://510kreport.com/company/led-technologies)
- Shenzhen Kaiyan Medical CO, Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical)
- Ningbo Hesi Electric Co., Ltd.: 1 (https://510kreport.com/company/ningbo-hesi-electric)
- Hunan Guangye Biotechnology Co., Ltd.: 1 (https://510kreport.com/company/hunan-guangye-biotechnology)
- Zhongshan Bisen Plastic Electronic Products Co., Ltd.: 1 (https://510kreport.com/company/zhongshan-bisen-plastic-electronic-products)
- Theragun, Inc.: 1 (https://510kreport.com/company/theragun)
- Sunglor Technology Co., Ltd.: 1 (https://510kreport.com/company/sunglor-technology)

## Firms that cite its devices most
- Shenzhen Ulike Smart Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-ulike-smart-electronics)
- Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-xinlong-precision-plastic-mold-products)
- Dongguan Boyuan Intelligent Technology Co.,Ltd: 1 (https://510kreport.com/company/dongguan-boyuan-intelligent-technology)
- Shenzhen Walton Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-walton-technology)
- Guangzhou Ahead Intelligent Technology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-ahead-intelligent-technology)
- Sunglor Technology Co., Ltd.: 1 (https://510kreport.com/company/sunglor-technology)
- Shenzhen Kaiyan Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical-equipment)
- Shenzhen Eyco Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-eyco-technology)

## Its most-cited devices
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), cited by 13

## Recent decisions
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (Sep 16, 2026)
- K261052: LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) (Jun 29, 2026)
- K260946: LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) (Jun 18, 2026)
- K260202: LED Light Therapy Masks (LumiLips FAC07NA) (Mar 23, 2026)
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (Feb 23, 2023)

Source page: https://510kreport.com/company/guangdong-newdermo-biotech