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ONA — Computer Assisted Hair Harvesting System Class II

FDA Device Classification

Classification Details

Product Code
ONA
Device Class
Class II
Regulation Number
882.4560
Submission Type
Review Panel
SU
Medical Specialty
Neurology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K173358restoration roboticsARTAS SystemMarch 16, 2018
K123548restoration roboticsTHE ARTAS SYSTEMFebruary 25, 2013
K123154restoration roboticsARTAS SYSTEM FROM RESTORATION ROBOTICSFebruary 19, 2013
K103428restoration roboticsTHE ARTAS SYSTEM FROM RESTORATION ROBOTICSApril 4, 2011