Cleared Traditional

K221188 - ZEPTO Precision Capsulotomy System (FDA 510(k) Clearance)

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

K221188 · Centricity Vision, Inc. · Ophthalmic device
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Jun 2022
Decision
59d
Days
Class 2
Risk

K221188 is an FDA 510(k) clearance for the ZEPTO Precision Capsulotomy System. Classified as Apparatus, Cutting, Radiofrequency, Electrosurgical, Ac-powered (product code PUL), Class II - Special Controls.

Submitted by Centricity Vision, Inc. (Carlsbad, US). The FDA issued a Cleared decision on June 23, 2022 after a review of 59 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Centricity Vision, Inc. devices

Submission Details

510(k) Number K221188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2022
Decision Date June 23, 2022
Days to Decision 59 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 110d · This submission: 59d
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.