HQLClass III
Intraocular Lens
21 CFR 886.3600 / Ophthalmic
HQL is the FDA product code for Intraocular Lens, a class III device type, regulated under 21 CFR 886.3600. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and 75 recalls.
Classification record
- Product code
- HQL
- Device name
- Intraocular Lens
- Regulation
- 21 CFR 886.3600
- Device class
- Class III
- Review panel
- Ophthalmic
- Submission type
- PMA
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 5
- Ingested recalls
- 75
Clearances, product code HQL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1984 | 2 |
| 1991 | 1 |
| 1992 | 1 |
Applicants with the most clearances
Product code HQL| Applicant | Clearances |
|---|---|
| American Medical Optics | 1 |
| California Intraocular Lens | 1 |
| Chiron Ophthalmics | 1 |
| Nidek, Inc. | 1 |
| Staar Surgical AG | 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.
