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U.S. Department of Health and Human Services

Product Classification

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Device accessories to examination light
Regulation Description AC-powered medical examination light.
Definition Accessories that attach to the light and assist in magnifying, clarifying, enhancing the image being viewed.
Physical State Lens, scopes
Technical Method Uses Lens to improve the image of the surface area being viewed under the light.
Target Area skin
Regulation Medical Specialty General Hospital
Review Panel General Hospital
Product CodePEQ
Premarket Review Office of Device Evaluation (ODE)
Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type 510(k)
Regulation Number 880.6320
Device Class 1
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible