HLP · Target, Fusion And Stereoscopic
Ophthalmic · 21 CFR 886.1880 · Class 1
Overview
| Product Code | HLP |
|---|---|
| Device Name | Target, Fusion And Stereoscopic |
| Regulation | 21 CFR 886.1880 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (§ 886.1870).
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 |
|---|---|---|---|---|
| K883471 | VKG 1000, VIDEO KERATOMETER | Technitex, Inc. | Nov 8, 1988 | SESE |
| K874251 | WORTH 4 DOT TEST DISTANCE C/W MUSCLE LIGHT | Richmond Products, Inc. | Jan 11, 1988 | SESE |
| K874250 | THREE CHAR. TEST-CHILD & WORTH 4 DOT TEST NEARPT. | Richmond Products, Inc. | Jan 11, 1988 | SESE |
Top Applicants
- Richmond Products, Inc. — 2 clearances
- Technitex, Inc. — 1 clearance
