Cleared Traditional

K923437 - BOSTON CLEANER II

K923437 is an FDA 510(k) clearance for BOSTON CLEANER II, 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 107-day FDA review.

K923437 · Polymer Technology Corp. · Ophthalmic device
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Oct 1992
Decision
107d
Days
Class 2
Risk

K923437 is an FDA 510(k) clearance for the BOSTON CLEANER II. 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 October 28, 1992 after a review of 107 days - within the typical 510(k) review window.

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 - K923437

510(k) Number K923437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date October 28, 1992
Days to Decision 107 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
3d faster than avg
Panel avg: 110d · This submission: 107d
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 K923437.
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · Alcon Laboratories · Dec 1997
BOSTON LIQUID ENZYMATIC CLEANER
K973217 · Polymer Technology Corp. · Nov 1997
BOSTON CONDITIONING SOLUTION
K923438 · Polymer Technology Corp. · Dec 1992
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