← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K963013 # PREFERENCE 60 AND PREFERENCE 60 TORIC (K963013) _CooperVision, Inc. · LPL · Dec 19, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K963013 ## Device Facts - **Applicant:** CooperVision, Inc. - **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md) - **Decision Date:** Dec 19, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5925 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use The Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters. ## Device Story Envoy and Envoy Toric are soft contact lenses manufactured from epsifilcon A. Lenses feature a molded back surface and a lathe-cut front surface. Designed for daily wear to correct refractive errors (myopia, hyperopia, astigmatism). Prescribed by eye care professionals for patients with non-diseased eyes. Lenses provide vision correction through physical refraction of light entering the eye. ## Clinical Evidence No clinical data provided in the document. ## Technological Characteristics Material: epsifilcon A. Design: molded back surface, lathe-cut front surface. Type: soft contact lens. Intended for daily wear. ## 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. ## 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} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 DEC 22 1997 Mr. Bernard F. Hallatt Manager, Quality Assurance and Regulatory Affairs CooperVision, Inc. 711 North Road Scottsville, NY 14546 Re: K963013 Trade Name: Envoy and Envoy Toric (epsifilcon A) Contact Lenses (clear and visibility tint with a molded back surface and a lathe cut front surface) Regulatory Class: II Product Code: 86 LPL Dated: October 7, 1997 Received: October 8, 1997 Dear Mr. Hallatt: We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the devices, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {1} Page 2 - Mr. Bernard F. Hallatt This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market. If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, A. Ralph Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2} Copervision 711 North Road Scottsville, New York 14546 (716) 385-6810 Fax (716) 889-5688 # Indications for Use Statement 510(k) Number: K963013 Device Name: Enovy Envoy Toric Indications for Use: The Envoy and Envoy Toric (epsifilcon A) Contact Lenses are indicated for daily wear by not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The spherical lenses may be worn by persons who exhibit astigmatism of 2.50 diopters or less, the toric lens by persons with astigmatism of 9.00 diopters. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ☑ or Over-the-Counter Use Daniel W. C. Brown PhD (Division Sign-Off) Division of Ophthalmic Devices 510(k) Number K963013 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K963013](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K963013) **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