Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PYRAMID SUNGLASSES/PYRAMID READING GLASSES

K-Number: K931328 · 1993-08-10

ApplicantPyramid
Decision Date1993-08-10
Product CodeHOI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PYRAMID SUNGLASSES/PYRAMID READING GLASSES is the device name listed in this FDA 510(k) record. The listed applicant is Pyramid. It received FDA 510(k) clearance on 1993-08-10 under 510(k) number K931328. The device is classified under product code HOI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PYRAMID SUNGLASSES/PYRAMID READING GLASSES?

PYRAMID SUNGLASSES/PYRAMID READING GLASSES is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Pyramid. The 510(k) number is K931328.

When did PYRAMID SUNGLASSES/PYRAMID READING GLASSES receive FDA 510(k) clearance?

PYRAMID SUNGLASSES/PYRAMID READING GLASSES received FDA 510(k) clearance on 1993-08-10, under 510(k) number K931328.

Who is the listed applicant for PYRAMID SUNGLASSES/PYRAMID READING GLASSES?

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

What is the FDA product code for PYRAMID SUNGLASSES/PYRAMID READING GLASSES?

The FDA product code for PYRAMID SUNGLASSES/PYRAMID READING GLASSES is HOI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Pyramid 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.

K914425PYRAMID SUNGLASSES/READING GLASSES

Related Devices (Code: HOI)

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.

K943613NILSing Wah International Enterprises , Ltd.K930435SPECTACLE FRAMESVenis DI A. VendrameK910329SUNGLASSESCutler & Gross Sloan Optical , Ltd.K854854SYSTEMS OF SIGHT LOW VISION EYEWAREInt'L Eye Care, Inc.K844716MAGNIFYING SPECTACLES W/PLASTIC LENSESGazelle Corp.K844038VISITEC MAGNIFYING SPECTACLESVisitec Co.

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.

↑