HMM · Distometer
Ophthalmic · 21 CFR 886.1190 · Class 1
Overview
| Product Code | HMM |
|---|---|
| Device Name | Distometer |
| Regulation | 21 CFR 886.1190 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A distometer is a device intended to measure the distance between the cornea and a corrective lens during refraction to help measure the change of the visual image when a lens is in place.
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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882575 | DISTOMETER | Hagg-Streit Service, Inc. | Jul 1, 1988 | SESE |
| K873440 | RULE, PUPILLARY | Allegheny Plastics, Inc. | Sep 21, 1987 | SESE |
Top Applicants
- Hagg-Streit Service, Inc. — 1 clearance
- Allegheny Plastics, Inc. — 1 clearance
