Cleared Traditional

K923438 - BOSTON CONDITIONING SOLUTION

K923438 is the FDA 510(k) clearance for BOSTON CONDITIONING SOLUTION by Polymer Technology Corp.. It is a Class 2 Ophthalmic device (product code LPN) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K923438 · Polymer Technology Corp. · Ophthalmic device
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Dec 1992
Decision
168d
Days
Class 2
Risk

K923438 is an FDA 510(k) clearance for the BOSTON CONDITIONING SOLUTION. Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Polymer Technology Corp. (Rochester, US). The FDA issued a Cleared decision on December 28, 1992 after a review of 168 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5928 - 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 Polymer Technology Corp. devices

Submission Details

510(k) Number K923438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date December 28, 1992
Days to Decision 168 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 110d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPN Accessories, Soft Lens Products
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5928
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 - LPN Accessories, Soft Lens Products

All 64
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K923438.
OPTI-FREE SUPRACLENS DAILY PROTEIN REMOVER
K974625 · Alcon Laboratories · Mar 1998
BAUSCH & LOMB2 SENSITIVE EYES MULTI-PURPOSE SOLUTION
K973921 · Bausch & Lomb, Inc. · Jan 1998
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · Alcon Laboratories · Dec 1997
OPTI-TEARS(R)
K890303 · Alcon Laboratories · Feb 1989
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · Bausch & Lomb, Inc. · Nov 1987
OPTI-ZYME(R)
K873548 · Alcon Laboratories · Sep 1987