FDA applicant

Castle Laser Systems, Limited

Chatham, NJ1 decision2012–20120 recalls

FDA records 1 decision for Castle Laser Systems, Limited (Chatham, NJ) in 2012: 1 510(k) clearance. All are in product code 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 Castle Laser Systems, Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Castle Laser Systems, Limited by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Castle”

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

Castle Co. 21

Castle Laser Systems, Limited

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Castle”