FDA applicant
Sanhe PERFECTLASER Technology Co., Ltd.
FDA records 1 decision for Sanhe PERFECTLASER Technology Co., Ltd. (Langfang, CN) in 2026: 1 510(k) clearance. All are in product code GEX (Powered Laser Surgical Instrument). 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 Sanhe PERFECTLASER Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2026.
Planning a device like Sanhe PERFECTLASER Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sanhe”
FDA records each applicant name separately; these may or may not be the same firm.