DeviceClearance

Product code HPZ— Ophthalmic

ALPHASPHERE ORBITAL IMPLANT

Classification name
Implant, Eye Sphere
Device class
Class 2
Regulation
21 CFR 886.3320
Advisory panel
Ophthalmic
Total cleared
39
First cleared
Most recent

Market context for product code HPZ

FDA has cleared 39 devices under product code HPZ between 1978 and 2022, filed by 23 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

last 15 years

Top applicants under product code HPZ

Recent clearances under product code HPZ

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