KYT · Light, Examination, Medical, Battery Powered
General Hospital · 21 CFR 880.6350 · Class 1
Overview
| Product Code | KYT |
|---|---|
| Device Name | Light, Examination, Medical, Battery Powered |
| Regulation | 21 CFR 880.6350 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A battery-powered medical examination light is a battery-powered device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination.
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 § 880.9. The device also 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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920782 | OLYMPIC TRANS-LITE | Olympic Medical Corp. | Mar 27, 1992 | SESE |
| K841589 | C-LITE | Suncoast Medical Manufacturers, Inc. | May 22, 1984 | SESE |
| K841588 | SUN-LITE WHITE SPOT | Suncoast Medical Manufacturers, Inc. | May 22, 1984 | SESE |
| K791001 | PENLIGHT/SWAB HOLDER | Concept, Inc. | Jun 22, 1979 | SESE |
| K781228 | PENLIGHTS | Abco Dealers, Inc. | Sep 7, 1978 | SESE |
| K760972 | TYCOS DIAGNOSTIC PENLIGHT | Taylor Instrument Analytics Co. | Jan 26, 1977 | SESE |
Top Applicants
- Suncoast Medical Manufacturers, Inc. — 2 clearances
- Abco Dealers, Inc. — 1 clearance
- Concept, Inc. — 1 clearance
- Olympic Medical Corp. — 1 clearance
- Taylor Instrument Analytics Co. — 1 clearance
