FDA.reportPublic FDA data

ZEPTO Precision Capsulotomy System

Primary DI
B560C20200
Brand
ZEPTO Precision Capsulotomy System
Company
MYNOSYS CELLULAR DEVICES, INC.
Model
C2020
Catalog number
C2020
Device description
Power Console
Published
2021-11-23
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

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
B560C20200PrimaryHIBCC0

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
7604565015nharrman@centricityvision.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
B560Z20200ZEPTO Precision Capsulotomy SystemZ2020Z20202021-11-23
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
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
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