Cleared Traditional

K911108 - OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS

K911108 · G.W.B. Intl., Ltd. · Ophthalmic device
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May 1991
Decision
70d
Days
-
Risk

K911108 is an FDA 510(k) clearance for the OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS. Classified as Plug, Punctum (product code LZU).

Submitted by G.W.B. Intl., Ltd. (Sudbury, US). The FDA issued a Cleared decision on May 13, 1991 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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 - K911108

510(k) Number K911108 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1991
Decision Date May 13, 1991
Days to Decision 70 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
40d faster than avg
Panel avg: 110d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

LZU Device Classification - Class 0,

Product Code LZU Plug, Punctum
Device Class -

Regulatory Peers - LZU Plug, Punctum

All 48
Devices cleared under the same product code (LZU) and FDA review panel - the closest regulatory comparables to K911108.
SILICONE PUNCTAL PLUG
K945906 · Oasis Medical, Inc. · Jan 1995
VISITEC CANALICULAR STENT
K915809 · Visitec Co. · Feb 1992
EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUG
K905427 · Eagle Vision, Inc. · Jun 1991
LACRIMAL PLUG
K905750 · Tamcenan Corp. · Mar 1991
LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANT
K897190 · Look, Inc. · Mar 1990
HERRICK LACRIMAL PLUG TM.
K896175 · Lacrimedics, Inc. · Jan 1990
K911108 · OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERS
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