HMH · Rack, Skiascopic
Ophthalmic · 21 CFR 886.1750 · Class 1
Overview
| Product Code | HMH |
|---|---|
| Device Name | Rack, Skiascopic |
| Regulation | 21 CFR 886.1750 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A skiascopic rack is a device that is a rack and a set of attached ophthalmic lenses of various dioptric strengths intended as an aid in refraction.
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 |
|---|---|---|---|---|
| K844364 | SKIASCOPIC RACKS | Luneau Laboratories | Jan 2, 1985 | SESE |
| K843195 | VISITEC FLIERINGA-LEGRAND FIXATION RING | Visitec Co. | Oct 5, 1984 | SESE |
Top Applicants
- Luneau Laboratories — 1 clearance
- Visitec Co. — 1 clearance
