Cleared Traditional

K923438 - BOSTON CONDITIONING SOLUTION

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

K923438 · Polymer Technology Corp. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923438

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
Combination Product No
PCCP Authorized No
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.

LPN Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K923438.
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
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · Polymer Technology Corp. · Nov 1997
BOSTON CLEANER II
K923437 · Polymer Technology Corp. · Oct 1992
OPTI-TEARS(R)
K890303 · Alcon Laboratories · Feb 1989
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · Bausch & Lomb, Inc. · Nov 1987