FDA applicant
Shenzhen Gsd Tech Co., Ltd.
FDA records 7 decisions for Shenzhen Gsd Tech Co., Ltd. (Shenzhen, CN) from 2009 to 2023: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 84 days from receipt to decision, against 89 for FDA’s reviews in the same codes and years. Its devices cite 10 predicates, 2 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 Shenzhen Gsd Tech 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 2009.
Planning a device like Shenzhen Gsd Tech 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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