Product code QQJ

Device name

Applicator, Negative Pressure, External, Ocular

Medical specialty

Ophthalmic

Device class

2

Regulation number

886.5000

Review panel

OP

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.

Source

FDA openFDA device classification dataset