Cleared Traditional

K233876 - UNITY VCS (8065000296)

Also marketed or referenced as:
UNITY CS (8065000297)

K233876 is an FDA 510(k) clearance for UNITY VCS (8065000296), manufactured by Alcon Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K233876 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2024
Decision
197d
Days
Class 2
Risk

K233876 is an FDA 510(k) clearance for the UNITY VCS (8065000296). Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on June 21, 2024 after a review of 197 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - 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 Alcon Laboratories, Inc. devices

FDA 510(k) Submission Details - K233876

510(k) Number K233876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2023
Decision Date June 21, 2024
Days to Decision 197 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
87d slower than avg
Panel avg: 110d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQC Device Classification - Class 2, Special Controls

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
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.

Regulatory Peers - HQC Unit, Phacofragmentation

All 193
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