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FDA 510(k)

SOFT LENS INSERTER

K-Number: K780931 · 1978-06-28

ApplicantSoft-Sert
Decision Date1978-06-28
Product CodeKYE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SOFT LENS INSERTER is the device name listed in this FDA 510(k) record. The listed applicant is Soft-Sert. It received FDA 510(k) clearance on 1978-06-28 under 510(k) number K780931. The device is classified under product code KYE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFT LENS INSERTER?

SOFT LENS INSERTER is a medical device that received FDA 510(k) clearance on 1978-06-28. The listed applicant is Soft-Sert. The 510(k) number is K780931.

When did SOFT LENS INSERTER receive FDA 510(k) clearance?

SOFT LENS INSERTER received FDA 510(k) clearance on 1978-06-28, under 510(k) number K780931.

Who is the listed applicant for SOFT LENS INSERTER?

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

What is the FDA product code for SOFT LENS INSERTER?

The FDA product code for SOFT LENS INSERTER is KYE.

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: KYE)

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.

K872567SOFT CONTACT LENS REMOVERMagnivision, Inc.K872591HARD CONTACT LENS REMOVER. ITEM #289Magnivision, Inc.K871130CONTACT LENS TWEEZERSS. M. C. Medi-Tech Corp.K870072SUMMIT OPTICS CONTACT LENS REMOVERDayton Mfg. Co.K850984MARLIN SOFT LENS HANDLERMarlin IndustriesK850983MARLIN SOFT LENS TWEEZERMarlin Industries

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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