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FDA 510(k)

LOW VISION ENHANCEMENT SYSTEM (LVES)

K-Number: K910124 · 1991-04-10

ApplicantTriangle Investments
Decision Date1991-04-10
Product CodeHPG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LOW VISION ENHANCEMENT SYSTEM (LVES) is the device name listed in this FDA 510(k) record. The listed applicant is Triangle Investments. It received FDA 510(k) clearance on 1991-04-10 under 510(k) number K910124. The device is classified under product code HPG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LOW VISION ENHANCEMENT SYSTEM (LVES)?

LOW VISION ENHANCEMENT SYSTEM (LVES) is a medical device that received FDA 510(k) clearance on 1991-04-10. The listed applicant is Triangle Investments. The 510(k) number is K910124.

When did LOW VISION ENHANCEMENT SYSTEM (LVES) receive FDA 510(k) clearance?

LOW VISION ENHANCEMENT SYSTEM (LVES) received FDA 510(k) clearance on 1991-04-10, under 510(k) number K910124.

Who is the listed applicant for LOW VISION ENHANCEMENT SYSTEM (LVES)?

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

What is the FDA product code for LOW VISION ENHANCEMENT SYSTEM (LVES)?

The FDA product code for LOW VISION ENHANCEMENT SYSTEM (LVES) is HPG.

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Related Devices (Code: HPG)

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.

K910601PATHFINDERNurion IndustriesK903558LASER CANENurion IndustriesK902187POLARONNurion IndustriesK862338SENSORY 6Brytech, Inc.K823385ALESOmsK761215F4912 NIGHT VISION AIDItt Corp.

Official Source

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

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