HLN · Gauge, Lens, Ophthalmic
Ophthalmic · 21 CFR 886.1420 · Class 1
Overview
| Product Code | HLN |
|---|---|
| Device Name | Gauge, Lens, Ophthalmic |
| Regulation | 21 CFR 886.1420 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic lens gauge is a calibrated device intended to manually measure the curvature of a spectacle lens.
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852054 | CONTACT LENS LOUPE, INSPETION LOUPE | Ascon Medical Instruments, Ltd. | Sep 5, 1985 | SESE |
| K801466 | LEIGH MEASURING SCALE #7725 | Edward Weck, Inc. | Jul 28, 1980 | SESE |
Top Applicants
- Ascon Medical Instruments, Ltd. — 1 clearance
- Edward Weck, Inc. — 1 clearance
