FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARTAS SYSTEM FROM RESTORATION ROBOTICS
K Number: K123154
·
Decision Feb 19, 2013
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
3
Applicant Total
4
Review Days
133
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ARTAS SYSTEM FROM RESTORATION ROBOTICS
- K Number
- K123154
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4560
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Restoration Robotics, Inc.
- Date Received
- October 9, 2012
- Decision Date
- February 19, 2013
- Product Code
- ONA
- Advisory Committee
- Neurology
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ONA | Computer Assisted Hair Harvesting System | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ONA), ordered by most recent decision date.
ARTAS System
FDA 510(k)
FDA Class 2
·Neurology
THE ARTAS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
THE ARTAS SYSTEM FROM RESTORATION ROBOTICS
FDA 510(k)
FDA Class 2
·Neurology