# Optikal (Southgate) Ltd (foreign exporter, Borehamwood, GB): 3 new FDA device listings, incl. lenses, soft contact, extended wear

**Score:** 65/100

| Field | Value |
|---|---|
| Establishment | Optikal (Southgate) Ltd |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Borehamwood, GB |
| New listings | 3 |
| Devices | Lenses, Soft Contact, Extended Wear; Lens, Contact, (Disposable); Lenses, Soft Contact, Daily Wear |
| Product codes | LPM, MVN, LPL |
| Device classes | Class II, Class III |
| Medical specialties | Ophthalmic |
| Brand names | Air optix Night and day lotrafilconB; Avaira Vitality (6 Pack) |
| First new listing | 2026-08-17 |
| Latest new listing | 2026-10-13 |
| FDA registration number | 3044710860 |
| Registration expires | 2027-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.