Cleared Special

K991130 - FLEXPLUG

K991130 · Eagle Vision, Inc. · Ophthalmic device
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Apr 1999
Decision
18d
Days
-
Risk

K991130 is an FDA 510(k) clearance for the FLEXPLUG. Classified as Plug, Punctum (product code LZU).

Submitted by Eagle Vision, Inc. (Memphis, US). The FDA issued a Cleared decision on April 20, 1999 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K991130

510(k) Number K991130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1999
Decision Date April 20, 1999
Days to Decision 18 days
Submission Type Special
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
92d faster than avg
Panel avg: 110d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

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 K991130.
OCCU-FLO PUNCTUM PLUGS
K001768 · U.S. Iol, Inc. · Sep 2000
BIOINSULATED SILICONE PUNCTUM PLUG
K001234 · Advanced Vision Science · Jul 2000
OPAQUE HERRICK PLUG, 0.3MM
K001737 · Lacrimedics, Inc. · Jun 2000
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · Advanced Vision Science · May 1998
SILICONE PUNCTAL PLUG
K980437 · Oasis Medical, Inc. · Apr 1998
PUNCTUAL OCCLUDER
K972523 · Odyssey Medical, Inc. · Sep 1997
K991130 · FLEXPLUG
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