510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103428Substantially Equivalent

The Artas System from Restoration Robotics

Venus Concept Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103428 is the FDA 510(k) clearance record for THE ARTAS SYSTEM FROM RESTORATION ROBOTICS, a class II device, cleared for Restoration Robotics, Inc. on under FDA product code ONA (Computer Assisted Hair Harvesting System). FDA's definition for product code ONA 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". FDA records list 15 510(k) clearances for VENUS CONCEPT INC., from to . As of , FDA records show no recalls naming K103428.

Clearance record

Decision date
Received
(133 days to decision)
Product code
ONA Computer Assisted Hair Harvesting System
Regulation
21 CFR 882.4560
Device class
Class II
Review panel
Neurology
Applicant
Restoration Robotics, Inc. 155-A Moffett Park Dr.,, Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ONA

Trailing 12 months

FDA records hold no clearances under product code ONA in the trailing twelve months.

FDA records show no clearances under product code ONA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ONA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260