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U.S. Department of Health and Human Services

Product Classification
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Device lens, surgical, laser, accesssory, ophthalmic laser
Regulation Description Ophthalmic laser.
Regulation Medical Specialty Ophthalmic
Review Panel Ophthalmic
Product CodeLQJ
Submission Type 510(k)
Regulation Number 886.4390
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Guidance Document
  • Guidance on the Content and Organization of a Premarket Notification for a Medical Laser
Third Party Review
Accredited Persons

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