FDA applicant
Precise Optics
FDA records 13 decisions for Precise Optics (Gardner, MA) from 1979 to 2003: 13 510(k) clearances. Most are in product codes FET (Endoscopic Video Imaging System/Component…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 1 predicate, 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 Precise Optics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Precise Optics since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Precise Optics’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 “Precise”
FDA records each applicant name separately; these may or may not be the same firm.