510(k) Report

FDA applicant

Jamar Medical Systems

San Diego, CA1 decision1991–19910 recalls

FDA records 1 decision for Jamar Medical Systems (San Diego, CA) in 1991: 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 Jamar Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jamar Medical Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Jamar Medical Systems’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

Which product codes does it file in?

  • GEXPowered Laser Surgical Instrument1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K913606Chrys XX CO2 Surgical Laser SystemJamar Medical Systems · 19911cites it

What has FDA decided for it lately?

  • K913606Chrys XX CO2 Surgical Laser SystemJamar Medical Systems · 1991

The one decision as Jamar Medical Systems →

Other applicant names beginning “Jamar”

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

Jamar Health Products 3