Lanard, Radio Shades, Sun Shades, Cool Shades, Kool Loops, Solar Spex, Shade Zone
510(k) K960628
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK960628 | Date4 Mar 1996 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- HQY
- Device Class
- Class I
- Regulation
- 21 CFR Part 886.5850
- Advisory Committee
- Ophthalmic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Lanard Radio Shades, Sun Shades, Cool Shades, Kool Loops, Solar Spex, and Shade Zone are classified as ophthalmic devices under the FDA’s product code HQY. These items are designed as protective eyewear, intended to shield the eyes from glare and light sources, including those from radios, sunlight, and other environmental factors. The collection includes various styles and names, all serving a similar purpose of reducing eye strain and discomfort in different settings.
These devices are supplied as non-sterile, single-use or reusable items, depending on the specific style, and are regulated under the FDA’s 510(k) clearance process. They were granted Substantially Equivalent status in 1996 under the Ophthalmic Advisory Committee (OP) and fall under FDA Class I classification. No third-party review was required for this submission, and the devices are intended for general consumer use without specific medical indications. Storage instructions are not detailed in the regulatory data, but typical eyewear maintenance applies.
Questions
AI-generated answers, 1 Oct 2026
What is the primary purpose of Lanard Radio Shades?
Lanard Radio Shades are designed as protective eyewear to shield eyes from glare and light sources, including those from radios, sunlight, and other environmental factors. They help reduce eye strain and discomfort in various settings, such as listening to radios or spending time outdoors.
Are Lanard Radio Shades sterile, and how are they intended for use?
Lanard Radio Shades are supplied as non-sterile items. They are classified as either single-use or reusable, depending on the specific style within the collection. Since they are intended for general consumer use without medical indications, typical eyewear maintenance applies for reuse.
What regulatory pathway does Lanard Radio Shades follow?
These devices were granted Substantially Equivalent (SE) status under the FDA’s 510(k) clearance process in 1996. They fall under the Ophthalmic Advisory Committee (OP) and are classified as FDA Class I devices. No third-party review was required for this submission.
What styles or variations are included in the Lanard Radio Shades collection?
The collection includes multiple styles named Radio Shades, Sun Shades, Cool Shades, Kool Loops, Solar Spex, and Shade Zone. While each has a distinct name, they all serve the same purpose of reducing glare and eye discomfort in different environments.
How should Lanard Radio Shades be stored?
The regulatory data does not specify detailed storage instructions for these devices. However, as typical eyewear, they should be stored in a clean, dry place away from direct sunlight and extreme temperatures to maintain their condition and functionality.