510(k) K170655

Device: Zepto
Applicant: Mynosys Cellular Devices, Inc.
510(k) number: K170655
Product code: PUL
Decision: Substantially Equivalent (SESE)
Decision date: 2017-06-02
Date received: 2017-03-03
Regulation: 886.4100
Classification name: Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
Medical specialty: Ophthalmic
Review panel: Ophthalmic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Dan Marinsik
Address: 46710 Fremont Blvd. Fremont CA US 94538 94538

FDA Registration Numbers#

3009746061
2030624
9681572
3011398014

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
B560Z20200	ZEPTO Precision Capsulotomy System	MYNOSYS CELLULAR DEVICES, INC.	2021-11-23
B560C20200	ZEPTO Precision Capsulotomy System	MYNOSYS CELLULAR DEVICES, INC.	2021-11-23

Other 510(k) Records For Product Code PUL #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K223763	ZeptoLink IOL Positioning System	Centricity Vision, Inc.	2023-04-11
K221188	ZEPTO Precision Capsulotomy System	Centricity Vision, Inc.	2022-06-23
K210827	ZEPTO Precision Capsulotomy System	Centricity Vision, Inc.	2021-12-14

Legacy Summary#

summary

FDA Review#

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