HOH · Spectacle, Operating (Loupe), Ophthalmic
Ophthalmic · 21 CFR 886.4770 · Class 1
Overview
| Product Code | HOH |
|---|---|
| Device Name | Spectacle, Operating (Loupe), Ophthalmic |
| Regulation | 21 CFR 886.4770 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.
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 (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K934494 | SURGITEL | General Scientific Corp. | Jan 25, 1994 | SESE |
| K875124 | LOW-POWER BINOCULAR LOUPE | Seiler Instrument & Mfg. Co., Inc. | Feb 19, 1988 | SESE |
| K810817 | EXETER OPERATING LOUPE | Exeter Instruments, Inc. | Apr 23, 1981 | SESE |
Top Applicants
- Exeter Instruments, Inc. — 1 clearance
- General Scientific Corp. — 1 clearance
- Seiler Instrument & Mfg. Co., Inc. — 1 clearance
