HJL · Lens, Condensing, Diagnostic
Ophthalmic · 21 CFR 886.1380 · Class 1
Overview
| Product Code | HJL |
|---|---|
| Device Name | Lens, Condensing, Diagnostic |
| Regulation | 21 CFR 886.1380 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A diagnostic condensing lens is a device used in binocular indirect ophthalmoscopy (a procedure that produces an inverted or reversed direct magnified image of the eye) intended to focus reflected light from the fundus of the eye.
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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K790526 | LIO-714 OPACITYMETER | Laser Industries , Ltd. | Nov 16, 1979 | SESE |
Top Applicants
- Laser Industries , Ltd. — 1 clearance
