510(k) Report

FDA applicant

Eclipse, Inc.

Palo Alto, CA1 decision1995–19950 recalls

FDA records 1 decision for Eclipse, Inc. (Palo Alto, CA) in 1995: 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 Eclipse, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Eclipse, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Eclipse, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Eclipse”

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