Cleared Traditional

K973217 - BOSTON LIQUID ENZYMATIC CLEANER

K973217 is an FDA 510(k) clearance for BOSTON LIQUID ENZYMATIC CLEANER, 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 89-day FDA review.

K973217 · Polymer Technology Corp. · Ophthalmic device
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Nov 1997
Decision
89d
Days
Class 2
Risk

K973217 is an FDA 510(k) clearance for the BOSTON LIQUID ENZYMATIC CLEANER. 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 November 24, 1997 after a review of 89 days - a notably fast clearance 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: 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 Polymer Technology Corp. devices

FDA 510(k) Submission Details - K973217

510(k) Number K973217 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1997
Decision Date November 24, 1997
Days to Decision 89 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
21d faster than avg
Panel avg: 110d · This submission: 89d
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 K973217.
SAUFLON ALL-IN-ONE LIGHT CONTACT LENS SOLUTION
K974485 · Szabocsik and Assoc. · Feb 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
BOSTON CONDITIONING SOLUTION
K923438 · Polymer Technology Corp. · Dec 1992
BOSTON CLEANER II
K923437 · Polymer Technology Corp. · Oct 1992
OPTI-TEARS(R)
K890303 · Alcon Laboratories · Feb 1989