← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K962185 # HYDRASOFT (EAST) AND HYDRASOFT TORIC(EAST) (METHAFILCON B) DAILY WEAR SOFT HYDROPHILIC CONTACT LENS (K962185) _CooperVision, Inc. · LPL · Dec 17, 1996 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K962185 ## Device Facts - **Applicant:** CooperVision, Inc. - **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md) - **Decision Date:** Dec 17, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5925 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. ## Device Story Hydrasoft (East) soft contact lens; spherical or toric design; composed of methafilcon B (hydroxyethylmethacrylate and methacrylic acid copolymer). Device functions as refractive medium on cornea to focus light on retina. Used by patients for vision correction. Manufactured via alternate process; equivalent to predicate Hydrasoft lenses. ## Clinical Evidence Bench testing only. Evaluated water content, light transmittance, refractive index, and mechanical properties per 1994 FDA guidance. Biocompatibility assessed via systemic injection and cytotoxicity testing. ## Technological Characteristics Material: methafilcon B (hydroxyethylmethacrylate and methacrylic acid copolymer). Form: spherical or toric soft contact lens. Function: refractive medium. Manufacturing: alternate polymerization process. ## Regulatory Identification A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water. ## Predicate Devices - Hydrasoft ([K962185](/device/K962185.md)) - Hydrasoft Toric ([K962185](/device/K962185.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K962185 CoperVision DEC 17 1996 East Coast Office 200 WillowBrook Office Park Fairport, New York 14450 (716) 385-6810 (800) 538-7824 Fax (716) 264-3279 West Coast Office 10 Faraday Irvine, California 92718 (714) 597-8130 (800) 341-2030 Fax (800) 209-0154 J. 510(k) SUMMARY Page 1 of 2 1. Submitter's Name: CooperVision, Inc. 711 North Road Scottsville, NY 14546 Phone: (716) 385-6810 FAX: (716) 889-5688 2. Contact Person: Bernard Hallatt Phone: (716) 264-3222 FAX: (716) 889-5688 3. Date Summary Prepared: May 1, 1996 4. Name of Device: - Trade Name: Hydrasoft (East) - Common Name: Soft Contact Lens - Classification Name: Soft (hydrophilic) Contact Lens (Per 21 CFR § 886.5925) 5. Legally Marketed Device: Hydrasoft® and Hydrasoft® Toric (methafilcon B) 6. Description of Device: The HYDRASOFT (East) (methafilcon B) Soft (hydrophilic) Contact lens is available as a spherical or astigmatic (toric) lens. The lens material, methafilcon B, is a random copolymer of hydroxyethylmethacrylate and methacrylic acid. When placed on the cornea in its hydrated state the HYDRASOFT (East) Contact Lens act as a refracting medium to focus light rays on the retina. 77 {1} 510(k) SUMMARY (Cont'd) Page 2 of 2 7. Intended Use: The HYDRASOFT (East) lens is intended for use as a daily wear lens for the correction of refractive ametropia (myopic, hyperopic and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes. 8. Technological Characteristics: The technological characteristics of the HYDRASOFT (East) spherical lens and HYDRASOFT TORIC (East) Lens are the same as the predicate device, Hydrasoft® and Hydrasoft® Toric. 9. Summary of Non-Clinical Tests: Physical and chemical properties testing was performed on lenses made using the alternate manufacturing method and polymerization process as called or in the May 1994 Premarket Notification (510(k)) Guidance Document For Daily Wear Contact Lenses. Water content, light transmittance, refractive index and mechanical properties were tested. Toxicity was determined by the Systemic Injection Test and Cytotoxicity Test along with company data incorporated by reference to an identical manufacturing process for tetrafilcon A lenses. 10. Conclusion: The determination of substantial equivalence is based on the results of non-clinical testing. Review of the all test data demonstrates methafilcon B lenses manufactured with the alternate manufacturing method and polymerization process are equivalent to the currently marketed Hydrasoft® and Hydrasoft® Toric contact lenses. The Hydrasoft (East) and Hydrasoft Toric (East) contact lenses have the same design, indication and directions for use as the Hydrasoft® and Hydrasoft® Toric contact lenses. CooperVision, Inc. concludes, therefore, that the Hydrasoft (East) and Hydrasoft Toric (East) contact lenses are substantially equivalent to the Hydrasoft® and Hydrasoft® Toric contact lenses. 78 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K962185](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K962185) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com