HQRClass II
Apparatus, Cautery, Radiofrequency, Ac-Powered
21 CFR 886.4100 / Ophthalmic
HQR is the FDA product code for Apparatus, Cautery, Radiofrequency, Ac-Powered, a class II device type, regulated under 21 CFR 886.4100. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- HQR
- Device name
- Apparatus, Cautery, Radiofrequency, Ac-Powered
- Regulation
- 21 CFR 886.4100
- 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
- 11
- Ingested recalls
- 0
Clearances, product code HQR
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1990 | 1 |
| 1994 | 2 |
| 1996 | 3 |
| 1998 | 2 |
| 1999 | 1 |
| 2005 | 1 |
Applicants with the most clearances
Product code HQR| Applicant | Clearances |
|---|---|
| Advanced Surgical Products, Inc. | 1 |
| C.M. Chance, Ltd. | 1 |
| Ellman Intl., Inc. | 1 |
| Gamp & Assoc. | 1 |
| Mentor O & O, Inc. | 1 |
| Mira, Inc. | 1 |
| Ophthalmic Technologies, Inc. | 1 |
| Refractec, Inc. | 1 |
| Microline Surgical, Inc | 1 |
| Storz | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Alcon Grieshaber AG
- Alcon Laboratories
- Alcon Laboratories Belgium
- Autocam Medical
- Biomerics
- HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.
- Isomedix Operations Inc
- Lake Region Medical
- Manufacturas y Servicios Internacionales, S. de R.L.
- MicroSurgical Technology Inc
- Midwest Sterilization Corp.
- RM Healthcare Products SA de CV
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.