FDA applicant

Sun Pharmaceutical Industries, Inc.

Billerica2 decisions1999–20240 recalls

FDA records 2 decisions for Sun Pharmaceutical Industries, Inc. (Billerica) from 1999 to 2024: 1 510(k) clearance and 1 original PMA approval. Most are in product codes MVF (System, Laser, Photodynamic Therapy) and 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, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Sun Pharmaceutical Industries, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Sun Pharmaceutical Industries, 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

Sun Pharmaceutical Industries, Inc.

Which product codes does it file in?

What has FDA decided for it lately?