HLR · Keratoscope, Battery-Powered
Ophthalmic · 21 CFR 886.1350 · Class 1
Overview
| Product Code | HLR |
|---|---|
| Device Name | Keratoscope, Battery-Powered |
| Regulation | 21 CFR 886.1350 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
| GMP Exempt | Yes |
Identification
A keratoscope is an AC-powered or battery-powered device intended to measure and evaluate the corneal curvature of the eye. Lines and circles within the keratoscope are used to observe the corneal reflex. This generic type of device includes the photokeratoscope which records corneal curvature by taking photographs of the cornea.
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 § 886.9. The battery-powered device is 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 (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K901553 | SURG-K SURGICAL KERATOMETER | The Sanborn Co. | Jul 20, 1990 | SESE |
| K882902 | QRK 100, QUALITATIVE RING KERATOSCOPE | Technitex, Inc. | Aug 4, 1988 | SESE |
| K882618 | JEDMED/POLACK KERATOSCOPE HS/SL | Gamut Ent. | Jul 13, 1988 | SESE |
| K864639 | REUSABLE SURGICAL KERATOSCOPE | Jedmed Instrument Co. | Dec 29, 1986 | SESE |
| K854054 | PLACIDO DISC | Cutler Medical Instruments | Dec 27, 1985 | SESE |
| K830008 | KARICKHOFF KERATOSCOPE | Surgidev Corp. | Jan 26, 1983 | SESE |
| K821080 | HAND KERATOSCOPE | Medical Equipment Designs, Inc. | May 24, 1982 | SESE |
Top Applicants
- Cutler Medical Instruments — 1 clearance
- Gamut Ent. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
- Medical Equipment Designs, Inc. — 1 clearance
- Surgidev Corp. — 1 clearance
