Ophthalmic— FDA advisory panel OP

The ophthalmic panel covers eye care from the exam lane to the operating room: slit lamps, tonometers, fundus cameras, optical coherence tomography systems, phacoemulsification platforms for cataract surgery, ophthalmic lasers, and the viscoelastics and single-use instruments that support ocular surgery. Ophthalmology was an early and steady adopter of imaging-analysis software, and OCT-adjacent analysis tools continue to clear here.

The panel's structural quirk is how much of the eye-device world it does not contain: daily-wear soft contact lenses largely clear via 510(k), but extended-wear lenses and intraocular lenses are PMA territory, and the first autonomous diabetic-retinopathy diagnostic famously arrived through the De Novo pathway rather than as a 510(k). For whole-market visibility in eye care, the 510(k) record is one panel of a triptych.