DeviceClearance

Product code PIC— Ophthalmic

BRAINPORT V100 DEVICE

Classification name
Oral Electronic Vision Aid
Device class
Class 2
Regulation
21 CFR 886.5905
Advisory panel
Ophthalmic
Total cleared
2
First cleared
Most recent

FDA classification definition

“To use as an oral electronic vision aid in conjunction with other assistive devices (e.g., the white cane, guide dog, etc.)”

— U.S. Food and Drug Administration, device classification record for product code PIC under 21 CFR 886.5905, via openFDA

Market context for product code PIC

FDA has cleared 2 devices under product code PIC, all in 2015, filed by 1 applicant company. 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.

Top applicants under product code PIC

Recent clearances under product code PIC

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