HJLClass I
Lens, Condensing, Diagnostic
21 CFR 886.1380 / Ophthalmic
HJL is the FDA product code for Lens, Condensing, Diagnostic, a class I device type, regulated under 21 CFR 886.1380. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.
Classification record
- Product code
- HJL
- Device name
- Lens, Condensing, Diagnostic
- Regulation
- 21 CFR 886.1380
- Device class
- Class I
- Review panel
- Ophthalmic
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 1
Clearances, product code HJL
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
Applicants with the most clearances
Product code HJL| Applicant | Clearances |
|---|---|
| Laser Industries, Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- 66 Vision Tech Co., Ltd.
- Aspen Surgical Products, Inc.
- Atc Technologies Inc.
- Beijing Hongdee Corporation
- Bioteque Corporation I-Lan Factory II
- Bioteque Corporation Yilan Science Park Factory
- Fci France Chirurgie Instrumentation
- Fci SAS
- Glaukos Corporation
- Heine Optotechnik GmbH & Co. KG.
- Hospital Equipment Mfg. Co.
- Ion Vision, 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.
