FDA.reportPublic FDA data

ZEPTO Precision Capsulotomy System

Primary DI
B560Z20200
Brand
ZEPTO Precision Capsulotomy System
Company
MYNOSYS CELLULAR DEVICES, INC.
Model
Z2020
Catalog number
Z2020
Device description
ZEPTO Disposable Handpiece with Fluid Isolator
Published
2021-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PULApparatus, Cutting, Radiofrequency, Electrosurgical, Ac-PoweredOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170655000ZeptoMynosys Cellular Devices, Inc.2017-06-02PUL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B560Z20200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7604565015nhartman@centricityvision.com

Regulatory Flags#

DUNS number
827036927
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B560C20230ZeptoLink IOL Positioning SystemC2023C20232023-06-16
B560Z20230ZeptoLinnk IOL Positioning SystemZ2023Z20232023-06-16
B560Z20240ZeptoLinnk IOL Positioning SystemZ2024Z20242023-06-16
B560E10000Zepto Capsulotomy SystemE1000E10002017-07-19
B560C20200ZEPTO Precision Capsulotomy SystemC2020C20202021-11-23
B560124300Zepto Capsulotomy System12430124302017-07-19
B560126840Zepto Capsulotomy System12684126842017-07-19
B560126860Zepto Capsulotomy System12686126862017-07-19
B560Z10000Zepto Capsulotomy SystemZ1000Z10002017-07-19
B560E10001Zepto Capsulotomy SystemE1000E10002017-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B560C20230ZeptoLink IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560Z20230ZeptoLinnk IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560Z20240ZeptoLinnk IOL Positioning SystemMYNOSYS CELLULAR DEVICES, INC.PUL2023-06-16
B560C20200ZEPTO Precision Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2021-11-23
B560E10000Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560124300Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560126840Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560126860Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560E10001Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19
B560Z10000Zepto Capsulotomy SystemMYNOSYS CELLULAR DEVICES, INC.PUL2017-07-19