Product code ONA

Device name

Computer Assisted Hair Harvesting System

Medical specialty

Neurology

Device class

2

Regulation number

882.4560

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

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.

Source

FDA openFDA device classification dataset