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.
| Device Type ID | 5479 |
| Device Name | Computer Assisted Hair Harvesting System |
| 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 Description | Stereotaxic Instrument. |
| Regulation Medical Specialty | Neurology |
| Review Panel | General & Plastic Surgery |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Surgical Devices (DSD) Plastic And Reconstructive Surgery Devices Branch One - Implants And Tools (PRSB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4560 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | ONA |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5479 |
| Device | Computer Assisted Hair Harvesting System |
| Product Code | ONA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Stereotaxic Instrument. |
| CFR Regulation Number | 882.4560 [🔎] |