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FDA 510(k)

HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%

K-Number: K952261 · 1995-07-05

ApplicantPilkington Barnes-Hind, Ltd.
Decision Date1995-07-05
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% is the device name listed in this FDA 510(k) record. The listed applicant is Pilkington Barnes-Hind, Ltd.. It received FDA 510(k) clearance on 1995-07-05 under 510(k) number K952261. 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 HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%?

HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% is a medical device that received FDA 510(k) clearance on 1995-07-05. The listed applicant is Pilkington Barnes-Hind, Ltd.. The 510(k) number is K952261.

When did HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% receive FDA 510(k) clearance?

HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% received FDA 510(k) clearance on 1995-07-05, under 510(k) number K952261.

Who is the listed applicant for HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%?

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

What is the FDA product code for HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55%?

The FDA product code for HYDROCURVE 3 TORIC, II, II 55% TORIC, II APHAKIC 55%, SOFT MATE II, CUSTOM EYES 55% is LPL.

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Other records listing Pilkington Barnes-Hind, 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.

K961299PRECISION UV (VASURFILCON A)K946012PRECISION UV(TM) (VASURFICON A)K944722PRECISION UV(TM) (VASURFILCON A)

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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