Cleared Traditional

K834261 - PLASTIC OPTICAL LENS M-110

K834261 is the FDA 510(k) clearance for PLASTIC OPTICAL LENS M-110 by U-Molde Systems, Inc.. It is a Class 2 Ophthalmic device (product code HQC) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K834261 · U-Molde Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1984
Decision
99d
Days
Class 2
Risk

K834261 is an FDA 510(k) clearance for the PLASTIC OPTICAL LENS M-110. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by U-Molde Systems, Inc. (Walker, US). The FDA issued a Cleared decision on March 16, 1984 after a review of 99 days - within the typical 510(k) review window.

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 U-Molde Systems, Inc. devices

Submission Details

510(k) Number K834261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1983
Decision Date March 16, 1984
Days to Decision 99 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 110d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 113
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K834261.
SITE SIMCOE STYLE I/A HANDPIECE
K842458 · Chiron Vision Corp. · Aug 1984
SITE COAXIAL I/A HANDPIECE 30 TIP
K840965 · Chiron Vision Corp. · May 1984
IOCARE IRRIGATION & ASPIRATION PACK
K834340 · Chiron Vision Corp. · Apr 1984
DISPOSABLE FIBER OPTIC ILLUMINATOR
K833465 · CooperVision, Inc. · Mar 1984
DISPOS. I/A & IRRIGATION HANDPIECES
K833783 · CooperVision, Inc. · Mar 1984
DISPOSABLE I/A HANDPIECE
K833784 · CooperVision, Inc. · Feb 1984