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U.S. Department of Health and Human Services

Product Classification
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Device laser marker or engraver, industrial or commercial
Definition A laser intended to mark or engrave an object with text, logos, etc. Using either a mask or a scanned laser beam.
Product CodeRHK
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? Yes
    Note: This device is also exempted from the GMP regulation, except for general requirements concerning records (820.180) and complaint files (820.198), as long as the device is not labeled or otherwise represented as sterile.
Summary Malfunction
Reporting		 Ineligible
Third Party Review Not Third Party Eligible
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