(398 days)
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).
GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens
This document is a 510(k) premarket notification approval letter for a contact lens. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is primarily administrative correspondence from the FDA to the device manufacturer, confirming substantial equivalence to a legally marketed predicate device.
Therefore, I cannot extract the requested information based on the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
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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
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.