Computer Assisted Hair Harvesting System

ONA · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560

Classification

FDA Product Code: ONA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.4560
Review panel: SU
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 4
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown