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Sign in to claim this brandRESTORATION ROBOTICS, INC.
US
Last updated May 24, 2026
What RESTORATION ROBOTICS, INC. makes
Restoration Robotics, Inc. manufactures robotic surgical arm systems designed for automated hair extraction procedures, including the ARTAS System and ARTAS iX. The company also produces disposable kits for site preparation and implantation, available in sterile and non-sterile variants, such as the Disposable Site Making & Implantation Kit and various sterile/non-sterile disposable kit models.
These devices are classified as Class II under FDA regulations and are listed via 510(k) clearance and the FDA’s Unique Device Identification (UDI) system. The company is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Restoration Robotics, Inc. manufacture?
Restoration Robotics, Inc. specializes in robotic surgical arm systems and disposable kits for hair extraction procedures. Their primary products include the ARTAS System and ARTAS iX, which are robotic arms used for automated follicular unit extraction (FUE) in hair restoration. They also supply disposable kits like the Disposable Site Making & Implantation Kit and various sterile/non-sterile disposable kits, which assist in preparing and implanting hair follicles during procedures.
Where is Restoration Robotics, Inc. based, and what is its primary focus?
Restoration Robotics, Inc. is headquartered in the United States. The company’s focus is on developing and manufacturing robotic surgical systems and disposable surgical kits specifically designed for automated hair extraction and transplantation, catering to the hair restoration market.
Which regulatory registries or databases list devices manufactured by Restoration Robotics, Inc.?
Devices from Restoration Robotics, Inc. are listed in the FDA’s 510(k) clearance database and the FDA’s Unique Device Identification (UDI) system. These registries confirm their compliance with U.S. regulatory requirements for Class II medical devices, ensuring traceability and authorization status for their robotic surgical systems and disposable kits.
How are the devices produced by Restoration Robotics, Inc. classified under FDA regulations?
All devices manufactured by Restoration Robotics, Inc. fall under Class II classification according to FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as robotic surgical systems and disposable kits used in hair extraction procedures.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 627212587
Catalogue (58)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX | 18G | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 19G 4 Prong 6mm Punch Long Bevel | FDA UDI | Class II | Active |
| Disposable Kits, Sterile and Non-Sterile (S) | 19G 4 Prong | FDA UDI | Class II | Active |
| Disposable Kit, Sterile and Non Sterile, iX | 18G 4 Prong | FDA UDI | Class II | Active |
| ARTAS System | Cart | FDA UDI | Class II | Active |
| Disposable Kit, Sterile (S) | 20G 4 Prong | FDA UDI | Class II | Active |
| Disposable Kits, Sterile and Non-Sterile (S) | 19G 2 Prong | FDA UDI | Class II | Active |
| ARTAS iX | Chair | FDA UDI | Class II | Active |
| Disposable Kit | Site Making | FDA UDI | Class II | Active |
| Disposable Kits, Sterile and Non-Sterile (S) | 20G 2 Prong | FDA UDI | Class II | Active |
| ARTAS System | Accessories Kit | FDA UDI | Class II | Active |
| Disposable Kits, 20G | 4 prong 6mm punch | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 18G 4 Prong 6mm Punch Long Bevel | FDA UDI | Class II | Active |
| Disposable Kits | 18G 4 Prong 4mm Punch | FDA UDI | Class II | Active |
| Disposable Kit, Sterile (S) | 19G 4 Prong | FDA UDI | Class II | Active |
| Disposable Kits, 20G | 2 prong 6mm punch | FDA UDI | Class II | Active |
| Disposable Kit | Non-Sterile Site Making | FDA UDI | Class II | Active |
| Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile | 18G 4 Prong | FDA UDI | Class II | Active |
| Reusable Kit | 18G/19G | FDA UDI | Class II | Active |
| Reusable Kit | Site Making | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 19G 2 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Kit, Sterile (S) | 20G 2 Prong | FDA UDI | Class II | Active |
| Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile | 18G 2 Prong | FDA UDI | Class II | Active |
| Disposable Kit, 20G Sterile | 4 prong 6mm punch | FDA UDI | Class II | Active |
| Disposable Kit | 19G 4 Prong 4mm Punch, Sterile | FDA UDI | Class II | Active |
| Disposable Kit | Sterile Site Making | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 19G 4 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 18G 4 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 18G 4 Prong 6mm Punch Long Bevel | FDA UDI | Class II | Active |
| Disposable Kits, Sterile and Non-Sterile (S) | 20G 4 Prong | FDA UDI | Class II | Active |
| ARTAS System | Chair | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 18G 2 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Kit, 20G Sterile | 2 prong 6mm punch | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 19G 2 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Kit, Sterile (S) | 18G 4 Prong | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 19G 4 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX | 19G | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 18G | FDA UDI | Class II | Active |
| Disposable Kit | 18G 4 Prong 4mm Punch, Sterile | FDA UDI | Class II | Active |
| Disposable Kit, Sterile (S) | 18G 2 Prong | FDA UDI | Class II | Active |
| Disposable Kit, Sterile and Non Sterile, iX | 19G 4 Prong | FDA UDI | Class II | Active |
| Disposable Kit | Non-Sterile | FDA UDI | Class II | Active |
| Disposable Kits, Sterile and Non-Sterile (S) | 18G 4 Prong | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 18G 4 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Kit | 18G Sterile | FDA UDI | Class II | Active |
| Disposable Accessories Kit | 19G 4 Prong 6mm Punch Long Bevel | FDA UDI | Class II | Active |
| Disposable Kit, Punch and Needle Assembly, 5 Pack Sterile | 19G 4 Prong | FDA UDI | Class II | Active |
| Disposable Kits | 19G 4 Prong 4mm Punch | FDA UDI | Class II | Active |
| Disposable Sterile Kit | 18G 2 Prong 6mm Punch | FDA UDI | Class II | Active |
| Disposable Kit | 19G Sterile | FDA UDI | Class II | Active |
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FDA Recalls (4)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Restoration Robotics, Inc. has four recall records, all initiated on 2013-10-13, with all listed as terminated. The reasons provided in each case involve reports of discoloration (residue) on the pins of the skin tensioner, attributed to insufficient cleaning of stainless steel pins during the passivation process, with the residue identified as a compound of iron and chlorine.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 13, 2013 | Z-0354-2014 | — | terminated | 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. |
| Oct 13, 2013 | Z-0356-2014 | — | terminated | 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. |
| Oct 13, 2013 | Z-0355-2014 | — | terminated | 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. |
| Oct 13, 2013 | Z-0353-2014 | — | terminated | 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. |