Surgical Headlight

FDA 510(k) K842515 · Good-Lite Co.

Substantially Equivalent

510(k) numberK842515

Submission

Device name
Surgical Headlight
Applicant
Good-Lite Co.
Mchenry, IL, US
Received
June 12, 1984
Decision date
August 2, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EBA – Light, Surgical Headlight
Device class
Class I (low risk)
Regulation
21 CFR 872.4630
Specialty
Dental

Other 510(k)s with product code EBA

510(k)DeviceApplicantDecision
K070287PS Series with Fiber Light Guide and Headlight, Models PS200, PS250, PS500EBA · Traditional Photonic Optische Gerate GmbH & Cokg02/12/2007SE
K923949Sylvan Dental Headlight SystemEBA · Traditional Sylvan Medical Fiberoptics10/16/1992SE
K893458Fiberoptic Headlight SystemEBA · Traditional Cuda Products Co.06/22/1989SE
K854646Vega Dental Operating LightEBA · Traditional Alpine Dental Equipment Co.03/06/1986SE
K842358IsolightEBA · Traditional Planmeca USA, Inc.07/31/1984SE
K822265Fiberoptic Light Source W/Related ItemsEBA · Traditional Kelleher Corp.09/28/1982SE
K810117Halogen Headlight SystemEBA · Traditional Colmed, Ltd.02/10/1981SE
K790807MetalitEBA · Traditional Harry J. Bosworth Co.08/03/1979SE
K790806PorcelitEBA · Traditional Harry J. Bosworth Co.08/03/1979SE

More from Harry J. Bosworth Co.

510(k)DeviceDecision
K842135Hi-Lo Floor Standing Exam. LightKZF · Traditional 07/06/1984SE
K833956Dot Visual Acvity Test 2000HOX · Traditional 01/04/1984SE

Questions and answers

When was Surgical Headlight cleared by the FDA?

Surgical Headlight (K842515) received a 510(k) decision of Substantially Equivalent on August 2, 1984, 51 days after the submission was received.

What is the product code of K842515?

The FDA product code is EBA – Light, Surgical Headlight, a Class I (low risk) device regulated under 21 CFR 872.4630.