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FDA 510(k)

LIFESTYLE BREAK THRU (POLYMACON)

K-Number: K965012 · 1997-03-11

ApplicantThe Lifestyle Co., Inc.
Decision Date1997-03-11
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LIFESTYLE BREAK THRU (POLYMACON) is the device name listed in this FDA 510(k) record. The listed applicant is The Lifestyle Co., Inc.. It received FDA 510(k) clearance on 1997-03-11 under 510(k) number K965012. 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 LIFESTYLE BREAK THRU (POLYMACON)?

LIFESTYLE BREAK THRU (POLYMACON) is a medical device that received FDA 510(k) clearance on 1997-03-11. The listed applicant is The Lifestyle Co., Inc.. The 510(k) number is K965012.

When did LIFESTYLE BREAK THRU (POLYMACON) receive FDA 510(k) clearance?

LIFESTYLE BREAK THRU (POLYMACON) received FDA 510(k) clearance on 1997-03-11, under 510(k) number K965012.

Who is the listed applicant for LIFESTYLE BREAK THRU (POLYMACON)?

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

What is the FDA product code for LIFESTYLE BREAK THRU (POLYMACON)?

The FDA product code for LIFESTYLE BREAK THRU (POLYMACON) 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 The Lifestyle Co., 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.

K000529LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)

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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