Lifestyle Break Thru (Polymacon)

FDA 510(k) K965012 · The Lifestyle Co., Inc.

Substantially Equivalent

510(k) numberK965012

Submission

Device name
Lifestyle Break Thru (Polymacon)
Applicant
The Lifestyle Co., Inc.
Morganville, NJ, US
Received
December 16, 1996
Decision date
March 11, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
LPL – Lenses, Soft Contact, Daily Wear
Device class
Class II (moderate risk)
Regulation
21 CFR 886.5925
Specialty
Ophthalmic

Other 510(k)s with product code LPL

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K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo…LPL · Traditional INTEROJO, Inc.05/29/2026SE
K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional Pegavision Corporation05/21/2026SE
K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Special Pegavision Corporation05/19/2026SE
K253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON…LPL · Traditional Geo Medical Co., Ltd.04/29/2026SE
K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional St. shine Optical Co., Ltd.03/19/2026SE
K252385Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision…LPL · Traditional Pegavision Corporation03/13/2026SE
K254052DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional Alcon Laboratories, Inc.02/13/2026SE
K251683Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking…LPL · Traditional Bruno Vision Care, LLC12/23/2025SE
K250364Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens…LPL · Traditional St. shine Optical Co., Ltd.10/07/2025SE
K244009Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily…LPL · Traditional Yung Sheng Optical Co., Ltd.09/25/2025SE

More from Yung Sheng Optical Co., Ltd.

510(k)DeviceDecision
K200747PuriLens Plus Preservative Free SalineLPN · Traditional 05/15/2020SE
K000529Lifestyle MV2 (TM) Toric (Polymacon) Soft (Hydrophilic) Multifocal Contact Lens for…LPL · Traditional 03/21/2000SE

Questions and answers

When was Lifestyle Break Thru (Polymacon) cleared by the FDA?

Lifestyle Break Thru (Polymacon) (K965012) received a 510(k) decision of Substantially Equivalent on March 11, 1997, 85 days after the submission was received.

What is the product code of K965012?

The FDA product code is LPL – Lenses, Soft Contact, Daily Wear, a Class II (moderate risk) device regulated under 21 CFR 886.5925.