HJI — Lens, Fundus, Hruby, Diagnostic Class I
FDA product code HJI covers "Lens, Fundus, Hruby, Diagnostic", a Class I medical device regulated under 21 CFR 886.1395. Submissions are reviewed by the Ophthalmic panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HJI
- Device Class
- Class I
- Regulation Number
- 886.1395
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923670 | ocular instruments | BYRNE EXPULSIVE LENS | November 16, 1992 |
| K902138 | academic catalyst | STRIPE PROJECTOR | July 5, 1990 |
| K901839 | canon usa | 60 FUNDUS CAMERA CF-60UV | July 5, 1990 |
| K897186 | innovision medical | LASER IMAGING WORK STATION | March 12, 1990 |
| K820223 | optical micro systems | OMS QUARTZ INFUSION CONTACT LENS | February 5, 1982 |
| K802927 | cooper medical devices | SEBESTYEN IRRIGATING CONTACT LENS | February 5, 1981 |
| K802971 | cooper medical devices | LANDERS CONTACT LENS | February 5, 1981 |
| K760949 | richard medical equip | CHARLES IRRIGATING FUNDUS CONTACT LENS | November 11, 1976 |