BOSTON CONTACT LENS CASE

K962512 · Polymer Technology Div. Wilmington Partners, L.P. · LRX · Jul 12, 1996 · Ophthalmic

Device Facts

• Record ID: K962512
• Device Name: BOSTON CONTACT LENS CASE
• Applicant: Polymer Technology Div. Wilmington Partners, L.P.
• Product Code: LRX · Ophthalmic
• Decision Date: Jul 12, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.

Device Story

Plastic, double-welled contact lens case; features ridged screw caps and elevated interior ridges to prevent lens adherence to surfaces. Used by patients for storage and disinfection of rigid gas permeable contact lenses. Device provides physical containment and mechanical separation to facilitate lens maintenance.

Clinical Evidence

No clinical data. Bench testing included Systemic Injection Test, Eye Irritation Test, and Cytotoxicity Test.

Technological Characteristics

Plastic construction; double-welled design with ridged screw caps; elevated interior ridges to prevent lens adherence.

Indications for Use

Indicated for disinfection and storage of rigid gas permeable contact lenses for patients using such lenses.

Regulatory Classification

Identification

A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.

Special Controls

*Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”

Predicate Devices

• BOSTON® Contact Lens Case (K951552)

Submission Summary (Full Text)

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Polymer Technology
K 962512
JUL 12 1996
Page 1 of 1

# BOSTON® Contact Lens Case

## Summary of Safety and Effectiveness

**Sponsor/Applicant:** Polymer Technology, a Division of Wilmington Partners L.P. 100 Research Drive Wilmington, MA 01887

**Trade/Proprietary Name:** BOSTON® Contact Lens Case

**Classification Name:** Contact lens case

**Common/Usual Name:** Contact lens case

**Contact:** Quality/Regulatory Affairs [phone]

**Statement of Equivalence:** Based on similar designs and on indications for use with rigid gas permeable contact lenses, The BOSTON Contact Lens Case is substantially equivalent to the following marketed product: BOSTON® Contact Lens Case (K951552)

**Device Description:** The BOSTON® Contact Lens Case is plastic and double-welled with ridged screw caps on the wells. The interiors of the wells and caps contain elevated ridges to prevent the adherence of rigid gas permeable contact lenses to the surfaces.

**Toxicology Testing:** In support of this premarket notification information from the following was submitted for review: Systemic Injection Test Eye Irritation Test Cytotoxicity Test

**Indications for Use:** The BOSTON Contact Lens Case is indicated for disinfection and storage of rigid gas permeable contact lenses.

V Final Lens Case 510(k)
033