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FDA 510(k)

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS

K-Number: K955366 · 1996-03-28

ApplicantRand Scientific Corp.
Decision Date1996-03-28
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Rand Scientific Corp.. It received FDA 510(k) clearance on 1996-03-28 under 510(k) number K955366. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS?

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS is a medical device that received FDA 510(k) clearance on 1996-03-28. The listed applicant is Rand Scientific Corp.. The 510(k) number is K955366.

When did TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS receive FDA 510(k) clearance?

TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS received FDA 510(k) clearance on 1996-03-28, under 510(k) number K955366.

Who is the listed applicant for TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS?

The FDA 510(k) record lists Rand Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS?

The FDA product code for TRANS-AIRE RIGID GAS PERMABLE CONTACT LENS is HQD.

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Other records listing Rand Scientific Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963856RAND NASAL PACKINGK961081SPIRIT RIDGE SILICONE CARVING BLOCKK955777PMMA CLASICK961057DURALASTIC SHEETING IIK961080MEDIAL MALAR IMPLANTK961072PEC IMPLANT

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Related Devices (Code: HQD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253822GPA (hexafocon A) Rigid Gas Permeable Contact LensesZhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact LensesAcuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact LensesTianjin Mastervision Technology Co., Ltd.K241571BostonSight® Specialty LensesBoston Foundation For Sight, Inc. D/B/A BostonsightK240618Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact LensAcuity Polymers, Inc.K233325Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)Visionary Optics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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