← Back to catalogue

Contact Lens Storage Case

FDA 510(k)

Class II (US FDA 510(k))

510(k) K121030

by Sacks Holdings, Inc.

Identifiers

510(k) Number
K121030 FDA 510(k)
FDA Product Code
LRX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5928 FDA 510(k)
Regulation Number
886.5928 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Contact Lens Storage Case is a device used for storing contact lenses. It is classified as a Case, Contact Lens, with a product code of LRX, and is used in the ophthalmic medical specialty.

The device is supplied as a single unit and is intended for use in storing contact lenses. It is a Class II device, with a regulation number of 886.5928, and has been cleared by the FDA with a 510K clearance, specifically K121030, with a decision date of 2012-07-06.

Frequently asked questions

What is the Contact Lens Storage Case used for?

The Contact Lens Storage Case is used for storing contact lenses, specifically in the ophthalmic medical specialty.

Is the Contact Lens Storage Case supplied as a single unit or in multiples?

The Contact Lens Storage Case is supplied as a single unit.

What is the regulatory classification of the Contact Lens Storage Case?

The Contact Lens Storage Case is classified as a Class II device with a regulation number of 886.5928.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Sacks Holdings Inc.'S Contact Lens Storage Case, K121030 - Sacks Holdings Inc.'S Contact Lens Storage Case, SACKS HOLDINGS INC.'S CONTACT LENS STORAGE CASE… - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sacks Holdings, Inc.

Sources (1)

  • FDA 510(k) K121030 24 fields · synced Oct 1, 2026