Cleared Traditional

K952260 - OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)

K952260 is an FDA 510(k) clearance for OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C), manufactured by Stellar Contact Lens, Inc.. The device is a Class 2 Ophthalmic device with product code HQD cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K952260 · Stellar Contact Lens, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1996
Decision
233d
Days
Class 2
Risk

K952260 is an FDA 510(k) clearance for the OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C). Classified as Lens, Contact (other Material) - Daily (product code HQD), Class II - Special Controls.

Submitted by Stellar Contact Lens, Inc. (Chicago, US). The FDA issued a Cleared decision on January 3, 1996 after a review of 233 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5916 - 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 - K952260

510(k) Number K952260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1995
Decision Date January 03, 1996
Days to Decision 233 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
123d slower than avg
Panel avg: 110d · This submission: 233d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HQD Device Classification - Class 2, Special Controls

Product Code HQD Lens, Contact (other Material) - Daily
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5916
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 - HQD Lens, Contact (other Material) - Daily

All 115
Devices cleared under the same product code (HQD) and FDA review panel - the closest regulatory comparables to K952260.
TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS
K955366 · Rand Scientific Corp. · Mar 1996
NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
K955900 · Novavision, Inc. · Mar 1996
O-PERM 30 A RIGID GAS PERMEABLE CONTACT LENS
K954124 · Optical Polymer Research, Inc. · Mar 1996
TRANS-AIRE RIGID GAS PERMEABLE CONTACT LENS
K952165 · Rand Scientific Corp. · Jun 1995
ROSE K LENS
K945955 · Rose K International , Ltd. · Feb 1995
ACCUCON
K944223 · Innovision, Inc. · Dec 1994
K952260 · OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
Download PDF FDA Summary Stellar Contact Lens,…