FDA 510(k)

GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS

K-Number: K962710 · 1996-09-05

Decision Date1996-09-05

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Gelflex Laboratories. It received FDA 510(k) clearance on 1996-09-05 under 510(k) number K962710. 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 GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS is a medical device that received FDA 510(k) clearance on 1996-09-05. The listed applicant is Gelflex Laboratories. The 510(k) number is K962710.

When did GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS receive FDA 510(k) clearance?

GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS received FDA 510(k) clearance on 1996-09-05, under 510(k) number K962710.

Who is the listed applicant for GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

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

What is the FDA product code for GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS?

The FDA product code for GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS 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 Gelflex Laboratories as applicant

K181558Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens K030027GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%K962711GELFLEX ALPHA (POLYMACON) 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.