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 Code | ONA |
Premarket Review |
Office of 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 |