510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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ONAClass II

Computer Assisted Hair Harvesting System

21 CFR 882.4560 / Neurology
FDA source (opens on fda.gov)

ONA is the FDA product code for Computer Assisted Hair Harvesting System, a class II device type, regulated under 21 CFR 882.4560. FDA's definition for this code reads: "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". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
ONA
Device name
Computer Assisted Hair Harvesting System
FDA 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.
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
4

Clearances, product code ONA

By decision year
4 clearances under product code ONA with a decision year between 2011 and 2018, 2013 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code ONA by decision year
YearClearances
20111
20132
20181

Applicants with the most clearances

Product code ONA
Applicants holding the most 510(k) clearances under product code ONA
ApplicantClearances
Venus Concept Inc.4

Companies listing this code with FDA

Companies whose registered establishments list this code