DeviceClearance

Product code HLL— Ophthalmic

ORTHOTONE

Classification name
Monitor, Eye Movement
Device class
Class 2
Regulation
21 CFR 886.1510
Advisory panel
Ophthalmic
Total cleared
4
First cleared
Most recent

Market context for product code HLL

FDA has cleared 4 devices under product code HLL between 1988 and 2023, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code HLL

Recent clearances under product code HLL

Data sourced from openFDA. This site is unofficial and independent of the FDA.