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FDA 510(k)

ACTIFRESH 400 LENS

K-Number: K983637 · 1999-12-10

ApplicantHydron , Ltd.
Decision Date1999-12-10
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ACTIFRESH 400 LENS is the device name listed in this FDA 510(k) record. The listed applicant is Hydron , Ltd.. It received FDA 510(k) clearance on 1999-12-10 under 510(k) number K983637. 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 ACTIFRESH 400 LENS?

ACTIFRESH 400 LENS is a medical device that received FDA 510(k) clearance on 1999-12-10. The listed applicant is Hydron , Ltd.. The 510(k) number is K983637.

When did ACTIFRESH 400 LENS receive FDA 510(k) clearance?

ACTIFRESH 400 LENS received FDA 510(k) clearance on 1999-12-10, under 510(k) number K983637.

Who is the listed applicant for ACTIFRESH 400 LENS?

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

What is the FDA product code for ACTIFRESH 400 LENS?

The FDA product code for ACTIFRESH 400 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.

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Other records listing Hydron , Ltd. 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.

K983160ACTITORIC (OCUFILCON A) SOFT (HYDROPHILIC) TORIC CONTACT LENS FOR DAILY WEAR

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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