Computer Assisted Hair Harvesting System
Neurology · 21 CFR 882.4560
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 MDR events
2 adverse event reports on file
Event type breakdown
Most-reported manufacturers
Recalls
4 recall events for this product code
- Restoration RoboticsTerminatedNov 18, 2013
Epsilon Skin Tensioner:Rx, Sterile
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Z-0353-2014 · View FDA record ↗ - Restoration RoboticsTerminatedNov 18, 2013
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Fol
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Z-0354-2014 · View FDA record ↗ - Restoration RoboticsTerminatedNov 18, 2013
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, foll
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Z-0355-2014 · View FDA record ↗ - Restoration RoboticsTerminatedNov 18, 2013
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384;
Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
Z-0356-2014 · View FDA record ↗
Registered firms
3 firms currently registered for this product code
510(k) clearances
4 clearances for this product code