FDA 510(k)

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)

K-Number: K970312 · 1997-04-02

Decision Date1997-04-02

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) is the device name listed in this FDA 510(k) record. The listed applicant is Flexlens, Inc.. It received FDA 510(k) clearance on 1997-04-02 under 510(k) number K970312. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)?

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) is a medical device that received FDA 510(k) clearance on 1997-04-02. The listed applicant is Flexlens, Inc.. The 510(k) number is K970312.

When did CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) receive FDA 510(k) clearance?

CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) received FDA 510(k) clearance on 1997-04-02, under 510(k) number K970312.

Who is the listed applicant for CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)?

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

What is the FDA product code for CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A)?

The FDA product code for CONTROLLED PROCESS RELEASE OF FLEXLENS (HEFILCON A) is LPL.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Flexlens, Inc. as applicant

K962000FLEXLENS(METHAFILCON A)K961943FLEXLENS K950294FLEXLENS 55 SOFT (HYDROPHILIC) CONTACT LENS

Related Devices (Code: LPL)

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.