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)

CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS

K-Number: K062541 · 2007-06-07

ApplicantInnova Vision, Inc.
Decision Date2007-06-07
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vision, Inc.. It received FDA 510(k) clearance on 2007-06-07 under 510(k) number K062541. 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 CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS?

CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS is a medical device that received FDA 510(k) clearance on 2007-06-07. The listed applicant is Innova Vision, Inc.. The 510(k) number is K062541.

When did CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS receive FDA 510(k) clearance?

CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS received FDA 510(k) clearance on 2007-06-07, under 510(k) number K062541.

Who is the listed applicant for CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS?

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

What is the FDA product code for CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS?

The FDA product code for CALAVIEW COLORS (ETAFILCON A) SOFT (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_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 Innova Vision, Inc. 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.

K240519Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact LensK232139Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact LensK222954Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact LensK213119Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact LensK112373CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATIONK083288DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER

View all 11 devices →

Related Devices (Code: LPL)

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.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

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.

↑