HPZClass II
Implant, Eye Sphere
21 CFR 886.3320 / Ophthalmic
HPZ is the FDA product code for Implant, Eye Sphere, a class II device type, regulated under 21 CFR 886.3320. As of , FDA records hold 39 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- HPZ
- Device name
- Implant, Eye Sphere
- Regulation
- 21 CFR 886.3320
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 39
- Ingested recalls
- 4
Clearances, product code HPZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1986 | 1 |
| 1987 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 1 |
| 1992 | 2 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 2 |
| 2003 | 1 |
| 2004 | 2 |
| 2006 | 1 |
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 2 |
| 2011 | 2 |
| 2013 | 1 |
| 2022 | 1 |
Applicants with the most clearances
Product code HPZ| Applicant | Clearances |
|---|---|
| Oculo Plastik, Inc. | 8 |
| Porex Surgical, Inc. | 6 |
| Integrated Orbital Implants Inc | 3 |
| Fci Ophthalmics, Inc. | 2 |
| Miguel Martinez M.D. | 2 |
| Becker & Associates Consulting, Inc. | 1 |
| Ceramisys Ltd | 1 |
| Evera Medical, Inc. | 1 |
| Fci (France Chirurgie Instrumentation) SAS | 1 |
| G.W.B. Intl., Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.