ARTAS iX
Model Chair · RESTORATION ROBOTICS, INC. · DI 00850470007531
ONA — Computer Assisted Hair Harvesting System · Class II · 21 CFR 882.4560
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (0)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
No dated reports to chart.
Regulatory clearances
- K173358 SESE 2018-03-16 (k number procode)
Predicate lineage
K173358 — cites (transitively): K103428 (d1), K103731 (d1), K123548 (d1), K072629 (d2), K952737 (d2) — cited as predicate by K221011
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — RESTORATION ROBOTICS, INC.
Nothing in the loaded window.