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U.S. Department of Health and Human Services

Product Classification

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Device computer assisted hair harvesting system
Regulation Description Stereotaxic instrument.
Definition A computer assisted harvesting system used in identifying and extracting hair follicular units and indicated to assist surgeon in identifying and extracting hair follicular units during hair transplantation.
Physical State computer assisted station with needle mechanism, force sensor, robotic arm and video imaging system
Technical Method computer assisted harvesting sysem
Target Area scalp
Regulation Medical Specialty Neurology
Review Panel General & Plastic Surgery
Product CodeONA
Premarket Review Surgical and Infection Control Devices (OHT4)
General Surgery Devices (DHT4A)
Submission Type 510(k)
Regulation Number 882.4560
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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