510(k) K170655
K170655 is an FDA 510(k) premarket notification submitted by Mynosys Cellular Devices, Inc. for the device "Zepto". The FDA issued a decision of Substantially Equivalent on June 2, 2017. The device falls under product code PUL (Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered), a Class II device regulated under 21 CFR 886.4100.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 2, 2017
- Date Received
- March 3, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.4100
- Review Panel
- OP
- Submission Type
Used to perform anterior capsulotomy during cataract surgery