510(k) K230510
K230510 is an FDA 510(k) premarket notification submitted by Cynosure, LLC for the device "MyEllevate". The FDA issued a decision of Substantially Equivalent on July 6, 2023. The device falls under product code GAT (Suture, Nonabsorbable, Synthetic, Polyethylene), a Class II device regulated under 21 CFR 878.5000. Cynosure, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 6, 2023
- Date Received
- February 24, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Suture, Nonabsorbable, Synthetic, Polyethylene
- Device Class
- Class II
- Regulation Number
- 878.5000
- Review Panel
- SU
- Submission Type