FDA applicant

Coherent Medical Division

Mchenry, IL7 decisions1979–19900 recalls

FDA records 7 decisions for Coherent Medical Division (Mchenry, IL) from 1979 to 1990: 6 510(k) clearances and 1 original PMA approval. Most are in product codes GEX (Powered Laser Surgical Instrument) and HKO (Refractometer, 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Coherent Medical Division since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Coherent”

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

Coherent Medical Group 27 Coherent Systems, Inc. 3 Coherent Radiation Laboratories 3 Coherent Medical Lasers 2 Coherent Star 2

Coherent Medical Division

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Coherent”