510(k) K210827
K210827 is an FDA 510(k) premarket notification submitted by Centricity Vision, Inc. for the device "ZEPTO Precision Capsulotomy System". The FDA issued a decision of Substantially Equivalent on December 14, 2021. The device falls under product code PUL (Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered), a Class II device regulated under 21 CFR 886.4100. Centricity Vision, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 2021
- Date Received
- March 19, 2021
- 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