510(k) K173358
K173358 is an FDA 510(k) premarket notification submitted by Restoration Robotics, Inc. for the device "ARTAS System". The FDA issued a decision of Substantially Equivalent on March 16, 2018. The device falls under product code ONA (Computer Assisted Hair Harvesting System), a Class II device regulated under 21 CFR 882.4560. Restoration Robotics, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2018
- Date Received
- October 25, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer Assisted Hair Harvesting System
- Device Class
- Class II
- Regulation Number
- 882.4560
- Review Panel
- SU
- Submission Type
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.