← Back to catalogue

Zepto

FDA 510(k)

Class II (US FDA 510(k))

510(k) K170655

by Mynosys Cellular Devices, Inc.

Identifiers

510(k) Number
K170655 FDA 510(k)
FDA Product Code
PUL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4100 FDA 510(k)
Regulation Number
886.4100 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Zepto is an Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-Powered device designed for ophthalmic use. It performs precise, circular capsulotomies during cataract surgery by delivering controlled radiofrequency pulses to the anterior lens capsule, ensuring reproducible and well-centered cuts.

Supplied as a disposable device, the Zepto is intended for single-use in sterile surgical settings. It operates under FDA_510K clearance (K170655) and falls under Device Class 2 regulations (886.4100). No MRI safety or reusable specifications are noted in the regulatory data.

Frequently asked questions

What specific type of surgical procedure is the Zepto designed for, and how does it function during that procedure?

The Zepto is designed for ophthalmic use during cataract surgery, specifically to perform precise, circular capsulotomies. It delivers controlled radiofrequency pulses to the anterior lens capsule, creating well-centered cuts that help remove the clouded lens while preserving capsule integrity. This ensures reproducible and accurate results during the procedure.

Is the Zepto intended for reuse, or is it meant to be used only once in a sterile setting?

The Zepto is explicitly supplied as a disposable device and is intended for single-use only in sterile surgical environments. This design minimizes cross-contamination risks and ensures consistent performance for each procedure.

What types of sizes or models are available for the Zepto, and how would a clinician determine the appropriate one for a patient?

The provided data does not specify distinct sizes or models for the Zepto, but it is designed for precise, circular capsulotomies during cataract surgery. Clinicians would rely on standard ophthalmic practice and the specific needs of the patient’s anterior lens capsule to determine the appropriate use, as the device is intended for general ophthalmic radiofrequency cutting applications.

How should the Zepto be stored before use, and are there any special handling instructions?

Since the Zepto is a single-use, disposable device intended for sterile surgical settings, it should be stored in its original packaging until use. The packaging is likely designed to maintain sterility, so it should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow manufacturer guidelines for unpacking and preparing the device for surgery.

What regulatory pathway was followed for the Zepto’s approval, and what class does it fall under?

The Zepto was cleared through the FDA’s 510(k) pathway (K170655) under Traditional review, demonstrating substantial equivalence to a predicate device. It is classified as a Class 2 medical device under FDA regulation 886.4100, which applies to ophthalmic electrosurgical cutting apparatuses. This classification reflects its intended use in controlled surgical environments.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Mynosys Cellular Devices | Ophthalmology Innovation Source, Mynosys Cellular Devices, Inc. Information - RocketReach, Mynosys Cellular Devices-VCBeat, Zepto Precision Pulse Capsulotomy by Mynosys Cellular Devices Inc ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mynosys Cellular Devices, Inc.

Sources (1)

  • FDA 510(k) K170655 24 fields · synced Sep 19, 2026