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)

BL1 (HARD CONTACT LENS)

K-Number: K864343 · 1986-11-28

ApplicantBeta Labs, Inc.
Decision Date1986-11-28
Product CodeHPX
DecisionSubstantially Equivalent

Device Summary

BL1 (HARD CONTACT LENS) is the device name listed in this FDA 510(k) record. The listed applicant is Beta Labs, Inc.. It received FDA 510(k) clearance on 1986-11-28 under 510(k) number K864343. The device is classified under product code HPX. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BL1 (HARD CONTACT LENS)?

BL1 (HARD CONTACT LENS) is a medical device that received FDA 510(k) clearance on 1986-11-28. The listed applicant is Beta Labs, Inc.. The 510(k) number is K864343.

When did BL1 (HARD CONTACT LENS) receive FDA 510(k) clearance?

BL1 (HARD CONTACT LENS) received FDA 510(k) clearance on 1986-11-28, under 510(k) number K864343.

Who is the listed applicant for BL1 (HARD CONTACT LENS)?

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

What is the FDA product code for BL1 (HARD CONTACT LENS)?

The FDA product code for BL1 (HARD CONTACT LENS) is HPX.

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

Related Devices (Code: HPX)

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.

K955777PMMA CLASICRand Scientific Corp.K940106KERATOPLASTY SUTURING LENSVisionary Technologies of Miami, Inc.K913081MULTI-VIEW BIFOCALSCamp Contact LensesK897021MARTIN-HENSLEY SEGMENT LENSBruce W. Martin O.D. and Edward HensleyK895411OPTIKEM PMMA CONTACT LENSOptikem Polymers, Inc.K874591ILLUMINATING INFUSION CONTACT LENS FOR EYE SURGERYVitreo Dynamics, 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.

↑