QQJ — Applicator, Negative Pressure, External, Ocular Class II
FDA product code QQJ covers "Applicator, Negative Pressure, External, Ocular", a Class II medical device regulated under 21 CFR 886.5000. Submissions are reviewed by the Ophthalmic panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QQJ
- Device Class
- Class II
- Regulation Number
- 886.5000
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
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.