Cleared Traditional

K873548 - OPTI-ZYME(R)

K873548 is an FDA 510(k) clearance for OPTI-ZYME, manufactured by Alcon Laboratories. The device is a Class 2 Ophthalmic device with product code LPN cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K873548 · Alcon Laboratories · Ophthalmic device
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Sep 1987
Decision
29d
Days
Class 2
Risk

K873548 is an FDA 510(k) clearance for the OPTI-ZYME(R). Classified as Accessories, Soft Lens Products (product code LPN), Class II - Special Controls.

Submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on September 29, 1987 after a review of 29 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.

FDA 510(k) Submission Details - K873548

510(k) Number K873548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1987
Decision Date September 29, 1987
Days to Decision 29 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
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 120
Devices cleared under the same product code (LPN) and FDA review panel - the closest regulatory comparables to K873548.
DURACLEAN DAILY CLEANER
K881987 · Allergan Optical · Jun 1988
BAUSCH & LOMB RENU REWETTING & LUBRICATING DROPS
K874364 · Bausch & Lomb, Inc. · Nov 1987
W-J STERILE TRI-FUNCTIONAL CONTACT LENS SOLUTION
K872973 · Wesley Jessen Corp. · Oct 1987
RESTORE
K872164 · Anderson Research, Inc. · Sep 1987
KESTREL CONTACT LENS CASE
K871714 · Applied Laboratories, Inc. · May 1987
CONTAC CASE
K863846 · S. M. C. Medi-Tech Corp. · Apr 1987
K873548 · OPTI-ZYME(R)
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