FDA applicant

Ocular Sciences Puerto Rico, Inc.

Rockville, MD7 decisions1997–20010 recalls

FDA records 7 decisions for Ocular Sciences Puerto Rico, Inc. (Rockville, MD) from 1997 to 2001: 7 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 16 predicates, 6 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, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Ocular Sciences Puerto Rico, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ocular Sciences Puerto Rico, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ocular Sciences Puerto Rico, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ocular Sciences Puerto Rico, Inc.’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) Report

Other applicant names beginning “Ocular”

FDA records each applicant name separately; these may or may not be the same firm.

Ocular Instruments, Inc. 50 Ocular Therapeutix, Inc. 2 Ocular Sciences 2 Ocular Innovations, Inc. 2 Ocular Blood Flow Laboratories, Inc. 2 Ocular Concepts, LLC 1 Ocular Pharmaceuticals, Inc. 1 Ocular Systems, Inc. 1

Ocular Sciences Puerto Rico, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Ocular”