HQFClass II
Laser, Ophthalmic
21 CFR 886.4390 / Ophthalmic
HQF is the FDA product code for Laser, Ophthalmic, a class II device type, regulated under 21 CFR 886.4390. As of , FDA records hold 180 510(k) clearances under this code, the most recent dated , and 32 recalls.
Classification record
- Product code
- HQF
- Device name
- Laser, Ophthalmic
- Regulation
- 21 CFR 886.4390
- Device class
- Class II
- Review panel
- Ophthalmic
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 180
- Ingested recalls
- 32
Clearances, product code HQF
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 16 |
| 1985 | 9 |
| 1986 | 7 |
| 1987 | 3 |
| 1988 | 7 |
| 1989 | 9 |
| 1990 | 3 |
| 1991 | 6 |
| 1993 | 4 |
| 1994 | 3 |
| 1995 | 2 |
| 1996 | 2 |
| 1997 | 5 |
| 1998 | 1 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 4 |
| 2003 | 2 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 2 |
| 2007 | 4 |
| 2008 | 3 |
| 2009 | 7 |
| 2010 | 2 |
| 2011 | 4 |
| 2012 | 5 |
| 2013 | 6 |
| 2014 | 3 |
| 2015 | 4 |
| 2016 | 3 |
| 2017 | 3 |
| 2018 | 1 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 7 |
| 2023 | 5 |
| 2024 | 3 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code HQF| Applicant | Clearances |
|---|---|
| Quantel Medical | 13 |
| Iridex Corporation | 13 |
| Lightmed Corp. | 10 |
| Ellex Medical Pty Ltd | 8 |
| Carl Zeiss Meditec Inc | 6 |
| American Medical Optics | 5 |
| Coherent Medical Group | 4 |
| Hgm, Inc. | 4 |
| Lumenis Ltd | 4 |
| Mira, Inc. | 4 |
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.