FDA applicant
Guangdong Newdermo Biotech Co., Ltd.
FDA records 5 decisions for Guangdong Newdermo Biotech Co., Ltd. (Guangzhou, CN) from 2023 to 2026: 5 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and NFO (Stimulator, Transcutaneous Electrical…). Since 2016 its 510(k)s took a median of 90 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Guangdong Newdermo Biotech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Guangdong Newdermo Biotech Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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