Halogen Headlight System
FDA 510(k) K810117 · Colmed, Ltd.
510(k) numberK810117
Submission
- Device name
- Halogen Headlight System
- Applicant
- Colmed, Ltd.
Mchenry, IL, US - Received
- January 16, 1981
- Decision date
- February 10, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code EBA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070287 | PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional | Photonic Optische Gerate GmbH & Cokg | 02/12/2007SE |
| K923949 | Sylvan Dental Headlight SystemEBA · Traditional | Sylvan Medical Fiberoptics | 10/16/1992SE |
| K893458 | Fiberoptic Headlight SystemEBA · Traditional | Cuda Products Co. | 06/22/1989SE |
| K854646 | Vega Dental Operating LightEBA · Traditional | Alpine Dental Equipment Co. | 03/06/1986SE |
| K842515 | Surgical HeadlightEBA · Traditional | Good-Lite Co. | 08/02/1984SE |
| K842358 | IsolightEBA · Traditional | Planmeca USA, Inc. | 07/31/1984SE |
| K822265 | Fiberoptic Light Source W/Related ItemsEBA · Traditional | Kelleher Corp. | 09/28/1982SE |
| K790807 | MetalitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
| K790806 | PorcelitEBA · Traditional | Harry J. Bosworth Co. | 08/03/1979SE |
More from Harry J. Bosworth Co.
| 510(k) | Device | Decision |
|---|---|---|
| K811209 | Jacob Wirz Transfixation PinELS · Traditional | 06/16/1981SE |
| K810636 | VariodrainGCY · Traditional | 05/01/1981SE |
| K801208 | Hollow Basket Titanium Dental ImplantELE · Traditional | 05/28/1980SE |
| K801006 | Charnley Design Hip ProsthesisJDG · Traditional | 05/20/1980SE |
| K800762 | PS3 Titanium Screw Dental ImplantDZE · Traditional | 05/14/1980SE |
| K792241 | PelimitIRN · Traditional | 11/30/1979SE |
Questions and answers
When was Halogen Headlight System cleared by the FDA?
Halogen Headlight System (K810117) received a 510(k) decision of Substantially Equivalent on February 10, 1981, 25 days after the submission was received.
What is the product code of K810117?
The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.