Phacofragmentor Tip
by M. Imonti and Associates Inc., 510(k)
Active
510(k) K933627
Overview
The Phacofragmentor Tip is a medical device used for phacofragmentation, which is a unit used in ophthalmic procedures. It is classified as a Class 2 device.
The device is supplied by M. Imonti and Associates Inc. and has been cleared by the FDA with the regulation number 886.4670 and product code HQC. It is intended for use in ophthalmic settings and is a single type of device, with no specified size or sterility information provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK933627 | Date25 Jan 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HQC
- Device Class
- Class II
- Regulation
- 21 CFR Part 886.4670
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent