Product code PUL— Ophthalmic

ZEPTO Precision Capsulotomy System

Classification name: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered
Device class: Class 2
Regulation: 21 CFR 886.4100
Advisory panel: Ophthalmic
Total cleared: 4
First cleared: 2017-06-02
Most recent: 2023-04-11

FDA classification definition

“Used to perform anterior capsulotomy during cataract surgery”
— U.S. Food and Drug Administration, device classification record for product code PUL under 21 CFR 886.4100, via openFDA

Market context for product code PUL

FDA has cleared 4 devices under product code PUL between 2017 and 2023, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

20231 clearance
20221 clearance
20211 clearance
20171 clearance

Top applicants under product code PUL

Centricity Vision, Inc.3 clearances
Mynosys Cellular Devices, Inc.1 clearance

Recent clearances under product code PUL

K223763 — ZeptoLink IOL Positioning SystemCentricity Vision, Inc.·2023-04-11
K221188 — ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.·2022-06-23
K210827 — ZEPTO Precision Capsulotomy SystemCentricity Vision, Inc.·2021-12-14
K170655 — ZeptoMynosys Cellular Devices, Inc.·2017-06-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.