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FDA 510(k)

CONTACT LENS WITH COLOR ADDITIVE

K-Number: K962911 · 1996-11-29

ApplicantCal Bionics
Decision Date1996-11-29
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

CONTACT LENS WITH COLOR ADDITIVE is the device name listed in this FDA 510(k) record. The listed applicant is Cal Bionics. It received FDA 510(k) clearance on 1996-11-29 under 510(k) number K962911. 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 CONTACT LENS WITH COLOR ADDITIVE?

CONTACT LENS WITH COLOR ADDITIVE is a medical device that received FDA 510(k) clearance on 1996-11-29. The listed applicant is Cal Bionics. The 510(k) number is K962911.

When did CONTACT LENS WITH COLOR ADDITIVE receive FDA 510(k) clearance?

CONTACT LENS WITH COLOR ADDITIVE received FDA 510(k) clearance on 1996-11-29, under 510(k) number K962911.

Who is the listed applicant for CONTACT LENS WITH COLOR ADDITIVE?

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

What is the FDA product code for CONTACT LENS WITH COLOR ADDITIVE?

The FDA product code for CONTACT LENS WITH COLOR ADDITIVE is LPL.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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