FDA applicant
Oculus Innovative Sciences
FDA records 16 decisions for Oculus Innovative Sciences (Petaluma, CA) from 2005 to 2017: 16 510(k) clearances. Most are in product codes FRO (Dressing, Wound, Drug) and PFP (Silicone Hydrogel For Scar Management). Since 2016 its 510(k)s took a median of 128 days from receipt to decision, against 222 for FDA’s reviews in the same codes and years. Its devices cite 32 predicates, 7 of them its own earlier devices. 5 recalls are linked to its devices.
FDA’s records also spell it “Oculus Innovative Sciences, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oculus Innovative Sciences’s devices, and how often a recall has named them.
FDA decisions per year
1in 2017
2026 so far, outlined.
Recalls per year
1in 2016
Class I Class II/III not classified
Planning a device like Oculus Innovative Sciences’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 “Oculus”
FDA records each applicant name separately; these may or may not be the same firm.