Accessories To Examination Light

Device Code: 2740

Product Code(s): PEQ

Definition: Accessories That Attach To The Light And Assist In Magnifying, Clarifying, Enhancing The Image Being Viewed.

Device Classification Information

Device Type ID2740
Device NameAccessories To Examination Light
Physical StateLens, Scopes
Technical MethodUses Lens To Improve The Image Of The Surface Area Being Viewed Under The Light.
Target AreaSkin
Regulation DescriptionAC-powered Medical Examination Light.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6320 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodePEQ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2740
DeviceAccessories To Examination Light
Product CodePEQ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionAC-powered Medical Examination Light.
CFR Regulation Number880.6320 [🔎]
TPLC Last Update: 2019-04-02 20:18:09

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