HJI · Lens, Fundus, Hruby, Diagnostic
Ophthalmic · 21 CFR 886.1395 · Class 1
Overview
| Product Code | HJI |
|---|---|
| Device Name | Lens, Fundus, Hruby, Diagnostic |
| Regulation | 21 CFR 886.1395 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K923670 | BYRNE EXPULSIVE LENS | Ocular Instruments, Inc. | Nov 16, 1992 | SESE |
| K902138 | STRIPE PROJECTOR | Academic Catalyst Corp. | Jul 5, 1990 | SESE |
| K901839 | 60 FUNDUS CAMERA CF-60UV | Canon USA, Inc. | Jul 5, 1990 | SESE |
| K897186 | LASER IMAGING WORK STATION | Innovision Medical, Inc. | Mar 12, 1990 | SESE |
| K820223 | OMS QUARTZ INFUSION CONTACT LENS | Optical Micro Systems, Inc. | Feb 5, 1982 | SESE |
| K802971 | LANDERS CONTACT LENS | Cooper Medical Devices Corp. | Feb 5, 1981 | SESE |
| K802927 | SEBESTYEN IRRIGATING CONTACT LENS | Cooper Medical Devices Corp. | Feb 5, 1981 | SESE |
| K760949 | CHARLES IRRIGATING FUNDUS CONTACT LENS | Richard'S Medical Equip., Inc. | Nov 11, 1976 | SESE |
Top Applicants
- Cooper Medical Devices Corp. — 2 clearances
- Academic Catalyst Corp. — 1 clearance
- Canon USA, Inc. — 1 clearance
- Innovision Medical, Inc. — 1 clearance
- Ocular Instruments, Inc. — 1 clearance
