HERRICK ULTIMATE PUNCTUM PLUG

K963501 · Lacrimedics, Inc. · LZU · Apr 14, 1997 · OP

Device Facts

• Record ID: K963501
• 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 ophthalmic device; inserted into punctum by clinician; occludes lacrimal duct; increases tear retention; treats dry eye, post-surgical conditions, and contact lens intolerance; enhances medication efficacy.

Clinical Evidence

No clinical data provided.

Technological Characteristics

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

Indications for Use

Indicated for patients with dry eye, post-surgical ocular conditions, contact lens-related issues, or as an adjunctive treatment aid to enhance medication efficacy.

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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K963501

Lacrimedics, Inc.
190 N. Arrowhead Ave., Suite B • Rialto, CA 92376-9908 USA
APR 14 1997

# 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 | 1.8 mm | 1.8 mm | 2.0 mm | 2.0 mm |
| diameter (typical) | 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 |

**Clinical tests:** None
**Adverse S&E information:** None

*David S. Herrick, MD*
CEO
*David S. Herrick, MD*
3-11-97

Telephone: [phone] (USA and Canada) • [phone] • Fax: [phone]