QQJ — Applicator, Negative Pressure, External, Ocular Class II
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN230055 | balance ophthalmics | FSYX Ocular Pressure Adjusting Pump (FSYX OPAP) System | June 27, 2024 |