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U.S. Department of Health and Human Services

Product Classification

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Device light, headband, surgical
Regulation Description Operating headlamp.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeFSR
Premarket Review Office of Device Evaluation (ODE)
Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
Intraocular and Corneal Implants Devices Branch (ICIB)
Submission Type 510(K) Exempt
Regulation Number 886.4335
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
    Note: FDA intends to propose exempting these devices from premarket notification pursuant to the criteria at sections 510(l) and 510(m) of the FD&C Act, subject to limitations on exemption criteria found in .9 of the associated classification regulation. Until the publication of a final rule or order exempting these devices from 510(k), FDA does not intend to enforce compliance with 510(k) requirements for these devices. FDA does not expect manufacturers to submit 510(k)s for these devices during this time period.
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons

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