Light, Surgical Headlight
The Surgical Headlight is a device worn by clinicians that provides a focused beam of light directed toward the surgical or treatment field, used in dental, oral surgical, and other clinical settings to improve visibility. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EBA and the applicable regulation is 21 CFR 872.4630, under the Dental medical specialty.
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Basic Information
- Product Code
- EBA
- Device Class
- FDA class 1
- Regulation Number
- 872.4630
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Feb 12, 2007 | Substantially Equivalent | Photonic Optische Gerate GmbH & Cokg |
| K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Oct 16, 1992 | Substantially Equivalent | Sylvan Medical Fiberoptics |
| K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Jun 22, 1989 | Substantially Equivalent | Cuda Products Co. |
| K854646 | VEGA DENTAL OPERATING LIGHT | Mar 06, 1986 | Substantially Equivalent | Alpine Dental Equipment Co. |
| K842515 | SURGICAL HEADLIGHT | Aug 02, 1984 | Substantially Equivalent | Good-Lite Co. |
| K842358 | ISOLIGHT | Jul 31, 1984 | Substantially Equivalent | Planmeca USA, Inc. |
| K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Sep 28, 1982 | Substantially Equivalent | Kelleher Corp. |
| K810117 | HALOGEN HEADLIGHT SYSTEM | Feb 10, 1981 | Substantially Equivalent | Colmed, Ltd. |
| K790807 | METALIT | Aug 03, 1979 | Substantially Equivalent | Harry J. Bosworth Co. |
| K790806 | PORCELIT | Aug 03, 1979 | Substantially Equivalent | Harry J. Bosworth Co. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.