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U.S. Department of Health and Human Services

Product Classification

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Device laser for gastro-urology use
Regulation Description Laser surgical instrument for use in general and plastic surgery and in dermatology.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Gastroenterology/Urology
Product CodeLNK
Premarket Review Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Reproductive, Gynecology and Urology Devices (DHT3B)
Submission Type 510(k)
Regulation Number 878.4810
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Recognized Consensus Standards
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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