Cleared Traditional

K022833 - BENJAMIN ENVOY PHACO HANDPIECE

K022833 is an FDA 510(k) clearance for BENJAMIN ENVOY PHACO HANDPIECE, manufactured by Benjamin Biomedical, Inc.. The device is a Class 2 Ophthalmic device with product code HQC cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K022833 · Benjamin Biomedical, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
14d
Days
Class 2
Risk

K022833 is an FDA 510(k) clearance for the BENJAMIN ENVOY PHACO HANDPIECE. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Benjamin Biomedical, Inc. (Appollo Beach, US). The FDA issued a Cleared decision on September 9, 2002 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K022833

510(k) Number K022833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date September 09, 2002
Days to Decision 14 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 110d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HQC Unit, Phacofragmentation

All 315
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K022833.
VENTURI PHACO PACK
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PERFECT CAPSULE
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DIGNITY OPHTHALMIC SURGICAL SYSTEM
K031404 · Phacor Inc., A Santen Company · May 2003
HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030
K020527 · American Optisurgical, Inc. · Jul 2002
INFINITI
K021566 · Alcon Laboratories, Inc. · Jul 2002
SURGE-FREE ASPIRATION ADAPTER
K020734 · Staar Surgical Co. · May 2002
K022833 · BENJAMIN ENVOY PHACO HANDPIECE
Download PDF FDA Summary Benjamin Biomedical, …