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Trans Aire Rigid Gas Permeable Contact Lens

by Rand Scientific Corp.

PMA P890044510(k) K955366

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK955366 Date28 Mar 1996ClearedStatusActive
United StatesFDA PMA PMA 1 supplement NumberP890044 Date7 May 1990ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k), FDA PMA Active

Specification

510(k) · PMA

Full name
Trans Aire (Tm) Rigid Gas Permeable Contact Lens
Generic Name
Lens, contact (other material) - daily
PMA Number
510(k) Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent
PMA Supplement
S008 (THIRTY DAY TRACK)

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Trans Aire Rigid Gas Permeable Contact Lens is a daily wear contact lens made from rigid gas permeable material, designed for ophthalmic use. It is classified as a Lens, contact (other material) - daily under FDA regulations.

This device is supplied as a reusable contact lens intended for daily wear and is manufactured by Rand Scientific Corp. It has received FDA authorization via both 510(k) (K952165) and PMA (P890044) pathways, with the most recent authorization being a supplement for location change.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Trans Aire Rigid Gas Permeable Contact Lens made of?

    The Trans Aire Rigid Gas Permeable Contact Lens is made of rigid gas permeable material, as specified in the device name and specifications, which identifies it as a lens constructed from this specific type of material for ophthalmic use.

  • Is the Trans Aire Rigid Gas Permeable Contact Lens intended for daily wear?

    Yes, the device is specified as a 'Lens, contact (other material) - daily' in the generic_name field, indicating it is designed for daily wear use as part of its classification and intended use.

  • What regulatory authorizations does the Trans Aire Rigid Gas Permeable Contact Lens have?

    The device has been authorized through both FDA 510(k) (k_number: K952165) and FDA PMA (pma_number: P890044) pathways, with a supplement (supplement_number: S008) submitted for a location change involving manufacturer, sterilizer, packager, or supplier.