Cleared Traditional

K170655 - Zepto (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170655 · Mynosys Cellular Devices, Inc. · Ophthalmic device
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Jun 2017
Decision
91d
Days
Class 2
Risk

K170655 is an FDA 510(k) clearance for the Zepto. Classified as Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered (product code PUL), Class II - Special Controls.

Submitted by Mynosys Cellular Devices, Inc. (Fremont, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4100 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mynosys Cellular Devices, Inc. devices

Submission Details

510(k) Number K170655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2017
Decision Date June 02, 2017
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PUL Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4100
Definition Used To Perform Anterior Capsulotomy During Cataract Surgery
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.