Product code KYT
- Device name
- Light, Examination, Medical, Battery Powered
- Medical specialty
- General Hospital
- Device class
- 1
- Regulation number
- 880.6350
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K920782 | OLYMPIC TRANS-LITE | Olympic Medical Corp. | 1992-03-27 |
| K841588 | SUN-LITE WHITE SPOT | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| K841589 | C-LITE | Suncoast Medical Manufacturers, Inc. | 1984-05-22 |
| K791001 | PENLIGHT/SWAB HOLDER | Concept, Inc. | 1979-06-22 |
| K781228 | PENLIGHTS | Abco Dealers, Inc. | 1978-09-07 |
| K760972 | TYCOS DIAGNOSTIC PENLIGHT | Taylor Instrument Analytics Co. | 1977-01-26 |
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| 20860008900368 | ClearSpec | Clearspec LLC | 2025-10-29 |
| 30886158010143 | Doctors Penlight | Beaver-Visitec International, Inc. | 2022-01-19 |
| 30886158010150 | Nurse-Mate® | Beaver-Visitec International, Inc. | 2022-01-19 |
| 00616784478210 | Reusable Penlight | Dynarex Corporation | 2021-09-01 |
| 00616784478111 | Disposable Penlight | Dynarex Corporation | 2021-09-01 |
| 08800012341014 | N/A | Bistos Co., Ltd. | 2021-06-07 |
| 10845854044346 | FLX-LITE | Conmed Corporation | 2020-09-24 |
| 10845854044353 | FLX-LITE | Conmed Corporation | 2020-09-24 |
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