510(k) Report

FDA applicant

Biophysic Medical, Inc.

Pleasant Hill, CA11 decisions1985–19950 recalls

FDA records 11 decisions for Biophysic Medical, Inc. (Pleasant Hill, CA) from 1985 to 1995: 11 510(k) clearances. Most are in product codes IYO (System, Imaging, Pulsed Echo, Ultrasonic) and HQF (Laser, Ophthalmic). 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, radiology panel, where it files most

How often FDA has decided Biophysic Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biophysic Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biophysic Medical, 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