Light, Examination, Medical, Battery Powered
The Battery Powered Medical Examination Light is a portable, battery-operated light source used by clinicians to illuminate body cavities, wound sites, or examination areas during physical assessment and minor procedures. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, and is exempt from Good Manufacturing Practice (GMP) requirements. The product code is KYT, regulated under 21 CFR 880.6350, in the General Hospital medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- KYT
- Device Class
- FDA class 1
- Regulation Number
- 880.6350
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K920782 | OLYMPIC TRANS-LITE | Mar 27, 1992 | Substantially Equivalent | Olympic Medical Corp. |
| K841589 | C-LITE | May 22, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
| K841588 | SUN-LITE WHITE SPOT | May 22, 1984 | Substantially Equivalent | Suncoast Medical Manufacturers, Inc. |
| K791001 | PENLIGHT/SWAB HOLDER | Jun 22, 1979 | Substantially Equivalent | Concept, Inc. |
| K781228 | PENLIGHTS | Sep 07, 1978 | Substantially Equivalent | Abco Dealers, Inc. |
| K760972 | TYCOS DIAGNOSTIC PENLIGHT | Jan 26, 1977 | Substantially Equivalent | Taylor Instrument Analytics Co. |
FEI Numbers
This FDA classification entry is associated with 156 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 156 registration numbers. Click on an entry to view related FDA registrations.