FDA Product Code PUL: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
Used To Perform Anterior Capsulotomy During Cataract Surgery
Leading manufacturers include Centricity Vision, Inc..
4
Total
4
Cleared
134d
Avg days
2017
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered Devices (Product Code PUL)
4 devices
Cleared
Apr 11, 2023
ZeptoLink IOL Positioning System
Centricity Vision, Inc.
Ophthalmic
117d
Cleared
Jun 23, 2022
ZEPTO Precision Capsulotomy System
Centricity Vision, Inc.
Ophthalmic
59d
Cleared
Dec 14, 2021
ZEPTO Precision Capsulotomy System
Centricity Vision, Inc.
Ophthalmic
270d
About Product Code PUL - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code PUL since 2017, with 4 receiving FDA clearance (average review time: 134 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
PUL devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →