DeviceClearance

Product code MYC— Ophthalmic

DRSplus

Classification name
Ophthalmoscope, Laser, Scanning
Device class
Class 2
Regulation
21 CFR 886.1570
Advisory panel
Ophthalmic
Total cleared
24
First cleared
Most recent

Market context for product code MYC

FDA has cleared 24 devices under product code MYC between 2006 and 2026, filed by 10 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 MYC

Recent clearances under product code MYC

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