FDA.reportPublic FDA data

Zepto Capsulotomy System

Primary DI
B560126840
Brand
Zepto Capsulotomy System
Company
MYNOSYS CELLULAR DEVICES, INC.
Model
12684
Catalog number
12684
Device description
Zepto Power Console
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B560126840PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure82 KiloPascal101 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Indoor use only
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5108576296dmarinsik@mynosys.com
5104153245swedgwood@mynosys.com

Regulatory Flags#

DUNS number
827036927
Device count
1
Serial number
true
Manufacturing 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
B560Z20200ZEPTO Precision Capsulotomy SystemZ2020Z20202021-11-23
B560124300Zepto Capsulotomy System12430124302017-07-19
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
B560Z20200ZEPTO 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
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