Cleared Traditional

K101122 - BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS

K101122 is an FDA 510(k) clearance for BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LA..., manufactured by Benz Research and Development Corp.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K101122 · Benz Research and Development Corp. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
110d
Days
Class 2
Risk

K101122 is an FDA 510(k) clearance for the BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Benz Research and Development Corp. (Sarasota, US). The FDA issued a Cleared decision on August 9, 2010 after a review of 110 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - 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.

FDA 510(k) Submission Details - K101122

510(k) Number K101122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2010
Decision Date August 09, 2010
Days to Decision 110 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
At panel average
Panel avg: 110d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
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 - LPL Lenses, Soft Contact, Daily Wear

All 486
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K092852 · St. shine Optical Co., Ltd. · Mar 2010
K101122 · BENZ-G 4X (HIOXIFILCON D) MULTIFOCAL LATHED LENS
Download PDF FDA Summary Benz Research and Dev…