Cleared Traditional

K941836 - UNILENS 38 SOFT ASPHERIC CONTACT LENS

K941836 is the FDA 510(k) clearance for UNILENS 38 SOFT ASPHERIC CONTACT LENS by Unilens Corp., USA. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K941836 · Unilens Corp., USA · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
85d
Days
Class 2
Risk

K941836 is an FDA 510(k) clearance for the UNILENS 38 SOFT ASPHERIC CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unilens Corp., USA (Largo, US). The FDA issued a Cleared decision on July 7, 1994 after a review of 85 days - a notably fast clearance cycle.

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: 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 Unilens Corp., USA devices

Submission Details

510(k) Number K941836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1994
Decision Date July 07, 1994
Days to Decision 85 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
25d faster than avg
Panel avg: 110d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 140
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K941836.
AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
K954139 · CooperVision, Inc. · Nov 1995
TETRAFILCON A HYDROPHILIC CONTACT LENSES
K950968 · CooperVision, Inc. · Jul 1995
BAUSCH & LOMB PREMIER 90 (BALAFILCON A) CONTACT LENS
K944895 · Bausch & Lomb, Inc. · Dec 1994
BAUSCH & LOMB MEDALIST 66 (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
K941370 · Bausch & Lomb, Inc. · May 1994