HNOClass I
Keratome, Ac-Powered
21 CFR 886.4370 / Ophthalmic
HNO is the FDA product code for Keratome, Ac-Powered, a class I device type, regulated under 21 CFR 886.4370. As of , FDA records hold 83 510(k) clearances under this code, the most recent dated , and 10 recalls.
Classification record
- Product code
- HNO
- Device name
- Keratome, Ac-Powered
- Regulation
- 21 CFR 886.4370
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 83
- Ingested recalls
- 10
Clearances, product code HNO
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1986 | 2 |
| 1987 | 1 |
| 1990 | 1 |
| 1991 | 3 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 4 |
| 1998 | 12 |
| 1999 | 3 |
| 2000 | 11 |
| 2001 | 6 |
| 2002 | 9 |
| 2003 | 5 |
| 2004 | 11 |
| 2005 | 3 |
| 2006 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2017 | 1 |
| 2018 | 1 |
Applicants with the most clearances
Product code HNO| Applicant | Clearances |
|---|---|
| Med-logics Inc | 7 |
| Millennium Biomedical, Inc. | 5 |
| Oasis Medical, Inc. | 5 |
| Bausch & Lomb Incorporated | 4 |
| Micro Specialties, Inc. | 4 |
| Moria SA | 4 |
| Surgin Surgical Instrumentation, Inc. | 4 |
| Howard Instruments, Inc. | 3 |
| Lasersight Technologies, Inc. | 3 |
| Plancon Instruments | 3 |
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.