HIT · Tester, Color Vision
Ophthalmic · 21 CFR 886.1170 · Class 1
Overview
| Product Code | HIT |
|---|---|
| Device Name | Tester, Color Vision |
| Regulation | 21 CFR 886.1170 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A color vision tester is a device that consists of various colored materials, such as colored yarns or color vision plates (multicolored plates which patients with color vision deficiency would perceive as being of one color), intended to evaluate color vision.
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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K903001 | SLIMCATH (TM) | Gynopharma, Inc. | Jun 25, 1991 | SESE |
| K875026 | ANOMALOSCOPE PLATE TEST - 5 [APT-5] | Lkc Technologies, Inc. | Feb 5, 1988 | SESE |
| K873908 | H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. | Richmond Products, Inc. | Dec 23, 1987 | SESE |
| K873911 | PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 | Richmond Products, Inc. | Dec 2, 1987 | SESE |
| K844694 | TITMUS VISION TESTER II | Titmus Optical, Inc. | Jan 22, 1985 | SESE |
| K844365 | COLOR VISION TESTERS | Luneau Laboratories | Jan 2, 1985 | SESE |
| K832843 | OSCAR COLOUR VISION TESTER | Keeler Instruments, Inc. | Jan 4, 1984 | SESE |
| K831074 | OSCAR COLOR VISION TESTER | Carl Zeiss, Inc. | Apr 28, 1983 | SESE |
| K810700 | CHROMOPS FM-100 COLOR VISION TESTER | Visidyne Corp. | Apr 10, 1981 | SESE |
Top Applicants
- Richmond Products, Inc. — 2 clearances
- Visidyne Corp. — 1 clearance
- Titmus Optical, Inc. — 1 clearance
- Luneau Laboratories — 1 clearance
- Lkc Technologies, Inc. — 1 clearance
