HJH · Loupe, Binocular, Low Power
Ophthalmic · 21 CFR 886.5120 · Class 1
Overview
| Product Code | HJH |
|---|---|
| Device Name | Loupe, Binocular, Low Power |
| Regulation | 21 CFR 886.5120 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects.
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K874845 | MALIS SURGICAL LOUPES | Valley Forge Scientific Corp. | Dec 23, 1987 | SESE |
| K863983 | EXETER OPERATING LOUPE | Exeter Instruments, Inc. | Nov 10, 1986 | SESE |
| K830878 | BINOCULAR LOUPE | Almore Intl., Inc. | Apr 6, 1983 | SESE |
Top Applicants
- Valley Forge Scientific Corp. — 1 clearance
- Exeter Instruments, Inc. — 1 clearance
- Almore Intl., Inc. — 1 clearance
