← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K110835 # GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (K110835) _GEO MEDICAL CO., LTD. · LPL · Apr 26, 2012 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K110835 ## Device Facts - **Applicant:** GEO MEDICAL CO., LTD. - **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md) - **Decision Date:** Apr 26, 2012 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5925 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not aphakic persons with non-diseased eyes. The lens is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule). ## Device Story GEO Magic Color is a soft (hydrophilic) contact lens made of polymacon. Used for daily wear to correct myopia and hyperopia in aphakic and non-aphakic patients. Available in clear or colored versions to enhance or alter eye appearance. Prescribed by eye care practitioners for frequent wear, requiring patient-performed cleaning, disinfection, and scheduled replacement. Device functions as a refractive optical aid. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on material properties and design characteristics consistent with predicate soft contact lenses. ## Technological Characteristics Material: Polymacon (hydrophilic polymer). Form factor: Soft contact lens. Intended for daily wear. Requires cleaning and disinfection. No electronic components or software. ## 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 Image /page/0/Picture/1 description: The image contains the words "Public Health Service" in a simple, sans-serif font. The text is arranged vertically, with "Public Health" on the first line and "Service" on the second line. The text is black against a white background. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 APR 2 6 2012 Geo Medical Co., Ltd. c/o Albert Rego, Ph. D. Official Correspondent Geo Medical Co., Ltd. 27001 La Paz Road, Suite 312 Mission Viejo, CA 92691 Re: K110835 Trade/Device Name: GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Codes: LPL Dated: March 21, 2012 Received: April 6, 2012 Dear Dr. Rego: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conimeres provision in May 20, 1978, are excordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, therefore, manel and include requirements for annual registration, listing of general controls provisions of vactice, labeling, and prohibitions against misbranding and devices, good manufacturing practice, as one of the grammation related to contract liability adulteration. Tease note: ODFET access as that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (bee above) Existing major regulations affecting your device can be filly be subject to addinonal controls. Enoung any of the 21, Parts 800 to 898. In addition, FDA may found in the Code of Feach. It successing your device in the Federal Register. {1}------------------------------------------------ Page 2 - Dr. Albert Rego Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance: You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Kesia Alexander Image /page/1/Picture/7 description: The image shows the handwritten word "for" in cursive script. The letter 'f' is elongated with a large loop extending below the baseline, and the letters 'o' and 'r' are connected in a flowing manner. The writing appears to be done with a pen or marker, and the overall style is elegant and fluid. Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known): KITU835 Device Name: GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens Indications for Use: GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakit and/or not rol ually weat to contection of Formative astigmative astigmatism up to 0.50 dioplers aphakic persons with non discussu eyos the ons is available clear or colored and may be used to enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule). × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) # (Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Marc Robbay (Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices 510(k) Number k110835 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K110835](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K110835) **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. 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