HQCClass II
Unit, Phacofragmentation
21 CFR 886.4670 / Ophthalmic
HQC is the FDA product code for Unit, Phacofragmentation, a class II device type, regulated under 21 CFR 886.4670. As of , FDA records hold 316 510(k) clearances under this code, the most recent dated , and 74 recalls.
Classification record
- Product code
- HQC
- Device name
- Unit, Phacofragmentation
- Regulation
- 21 CFR 886.4670
- 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
- 316
- Ingested recalls
- 74
Clearances, product code HQC
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 20 |
| 1984 | 30 |
| 1985 | 25 |
| 1986 | 14 |
| 1987 | 9 |
| 1988 | 7 |
| 1989 | 9 |
| 1990 | 8 |
| 1991 | 7 |
| 1992 | 8 |
| 1993 | 7 |
| 1994 | 20 |
| 1995 | 34 |
| 1996 | 19 |
| 1997 | 11 |
| 1998 | 7 |
| 1999 | 2 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 4 |
| 2003 | 3 |
| 2004 | 1 |
| 2005 | 2 |
| 2006 | 2 |
| 2008 | 4 |
| 2009 | 5 |
| 2010 | 3 |
| 2011 | 5 |
| 2012 | 5 |
| 2014 | 4 |
| 2015 | 3 |
| 2016 | 1 |
| 2017 | 3 |
| 2019 | 4 |
| 2020 | 4 |
| 2021 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 2 |
Applicants with the most clearances
Product code HQC| Applicant | Clearances |
|---|---|
| Storz Instrument Co. | 17 |
| Advanced Medical Optics, Inc. | 16 |
| Chiron Vision Corp. | 15 |
| CooperVision, Inc. | 15 |
| Site Microsurgical Systems, Inc. | 14 |
| Bausch & Lomb Incorporated | 13 |
| Alcon Laboratories | 12 |
| Surgin Surgical Instrumentation, Inc. | 8 |
| Carl Zeiss Meditec Cataract Technology Inc | 7 |
| Staar Surgical AG | 6 |
Companies listing this code with FDA
Companies whose registered establishments list this code- ABA Medical Technology Co Ltd
- Advanced Medical Optics, Inc.
- Alcon Grieshaber AG
- Alcon Laboratories
- Alcon Laboratories Belgium
- Autocam Medical
- AvailMed S.A.De C.V.
- Bausch & Lomb Incorporated
- Bausch+Lomb Netherlands B.V. Amsterdam Logistics Centre
- BGS Beta Gamma Service GmbH & Co KG
- Can Technomed Trading Ltd.
- Carl Zeiss Meditec Cataract Technology Inc
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.