DeviceClearance

Product code ORZ— Ophthalmic

TearCare MGX System

Classification name
Eyelid Thermal Pulsation System
Device class
Class 2
Regulation
21 CFR 886.5200
Advisory panel
Ophthalmic
Total cleared
13
First cleared
Most recent

FDA classification definition

“Therapeutic application of heat and massage to the eyelids.”

— U.S. Food and Drug Administration, device classification record for product code ORZ under 21 CFR 886.5200, via openFDA

Market context for product code ORZ

FDA has cleared 13 devices under product code ORZ between 2011 and 2026, 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 ORZ

Recent clearances under product code ORZ

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