HERRICK ULTIMATE PUNCTUM PLUG

K963708 · Lacrimedics, Inc. · LZU · Apr 14, 1997 · OP

Device Facts

• Record ID: K963708
• Device Name: HERRICK ULTIMATE PUNCTUM PLUG
• Applicant: Lacrimedics, Inc.
• Product Code: LZU · OP
• Decision Date: Apr 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated.

Device Story

Flexible silicone punctum plug; inserted into punctum by clinician; occludes lacrimal duct; reduces lacrimal flow; increases tear retention; treats dry eye, post-surgical conditions, contact lens intolerance; enhances medication efficacy.

Clinical Evidence

No clinical data provided; device relies on established material safety and functional equivalence to predicate devices.

Technological Characteristics

Material: Medical grade silicone. Form factor: Flexible plug, 1.8mm length, 0.8mm diameter. Principle: Mechanical occlusion of the punctum.

Indications for Use

Indicated for patients requiring treatment of dry eye, post-surgical eye care, enhancement of medication efficacy, treatment of contact lens-related issues, or as an adjunctive treatment aid.

Predicate Devices

• Tapered-Shaft Punctum Plug (Eagle Vision and Ciba Vision)
• Soft Plug (Oasis)
• Punctum Plug (FCI Ophthalmics)

Submission Summary (Full Text)

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LACRIMEDICS, INC.

APR 14 1997

K963708

190 N. Arrowhead Ave., Suite B • Rialto, CA 92376-9908 USA

# 510(k) NOTIFICATION SUMMARY

| Device name: | Herrick Ultimate Punctum Plug |
| --- | --- |
| Device common name: | Punctum Plug |
| Classification name: | Punctum Plug (86LZU) |
| Predicate devices: | Tapered-Shaft Punctum Plug (marketed by Eagle Vision and Ciba Vision) |
| | Soft Plug™ (marketed by Oasis) |
| | Punctum Plug (marketed by FCI Ophthalmics) |
| Device description: | A flexible silicone ophthalmic device designed to fit and be retained in the punctum. |
| Device use: | Used to enhance retention of eye fluids by occlusion of one or more punctum, reducing lacrimal flow. Useful for treatment of dry eye and other conditions where enhancement of tear retention is indicated. |

Comparison to predicate devices:

| Device name
Features | Herrick Ultimate
Punctum Plug
(Lacrimedics) | Tapered Shaft Punctum
Plug
(Eagle Vision & Ciba) | Soft Plug
(Oasis) | Punctum Plug
(FCI Ophthalmics) |
| --- | --- | --- | --- | --- |
| 1. Indications
claimed | Treatment of dry eye
After eye surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment aid | Treatment of dry eye | Treatment of dry eye
After eye surgery
Enhance efficacy of
medications
Treatment of contact
lens problems
Adjunctive treatment aid | (Not available) |
| 2. Function | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention | Causes occlusion of
punctum, resulting in
greater tear retention |
| 3. Design - length
diameter (typical) | 1.8 mm | 1.8 mm | 2.0 mm | 2.0 mm |
| | 0.8 mm | 0.7 mm | 0.9 mm | 0.8 mm |
| 4. Material | Medical grade silicone | Medical grade silicone | Medical grade silicone | Medical grade silicone |


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