HPA · Frame, Trial, Ophthalmic
Ophthalmic · 21 CFR 886.1415 · Class 1
Overview
| Product Code | HPA |
|---|---|
| Device Name | Frame, Trial, Ophthalmic |
| Regulation | 21 CFR 886.1415 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
An opthalmic trial lens frame is a mechanical device intended to hold trial lenses for vision testing.
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 (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852548 | ATL 225 MW TRAIL LENS SET | Ascon Medical Instruments, Ltd. | Jul 31, 1985 | SESE |
| K852126 | ATF 101 TRAIL FRAME | Ascon Medical Instruments, Ltd. | Jun 5, 1985 | SESE |
| K841768 | WOODLYN LIGHTWEIGHT TRIAL FRAME | Woodlyn, Inc. | Jun 1, 1984 | SESE |
| K833669 | IMAGE DEFLECTOR | Michael Onufryk | Mar 27, 1984 | SESE |
| K821084 | UNIVERSAL TRIAL FRAMEE | Medical Equipment Designs, Inc. | Jun 14, 1982 | SESE |
Top Applicants
- Ascon Medical Instruments, Ltd. — 2 clearances
- Medical Equipment Designs, Inc. — 1 clearance
- Michael Onufryk — 1 clearance
- Woodlyn, Inc. — 1 clearance
