← Product Code [LRX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX) · K033656 # SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE (K033656) _Sauflon Pharmaceuticals, Ltd. · LRX · Feb 2, 2004 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K033656 ## Device Facts - **Applicant:** Sauflon Pharmaceuticals, Ltd. - **Product Code:** [LRX](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX.md) - **Decision Date:** Feb 2, 2004 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5928 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use The SAUFLON Flat and Barrel Lens Case are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection. ## Device Story Moulded plastic contact lens cases; flat or barrel-style designs with screw-top lids. Barrel style includes internal lens basket for storage. Used by contact lens wearers for chemical disinfection and storage of lenses. Device provides physical containment during chemical disinfection process. Benefits include safe storage and maintenance of contact lenses. ## Clinical Evidence Bench testing only. Cytotoxicity, systemic toxicity, and ocular irritation studies performed. Results showed no evidence of cellular or systemic toxicity or ocular irritation. ## Technological Characteristics Moulded plastic construction; flat or barrel-style form factor; screw-top lids; barrel style includes lens basket. Non-powered, passive device. ## Regulatory Identification A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat. ## Special Controls *Classification.* Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.” ## Predicate Devices - Bausch and Lomb Lens Case ## 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}------------------------------------------------ Image /page/0/Picture/1 description: The image shows a logo for Salifron Pharmaceutical Limited. The logo consists of a stylized image of a water droplet on the left, and the company name on the right. The company name is written in a simple, sans-serif font. # FEB - 2 2004 510(k) Summary K033656 # SUBMITTER INFORMATION: | Company Name: | Sauflon Pharmaceuticals Ltd. | |------------------------|-----------------------------------------------------------| | Address: | 49 – 53 York Street
Twickenham
Middlesex
TW1 3LP | | Phone: | 020 8322 4200 | | Fax: | 020 8891 3001 | | Official Correspondent | Dr Ligia Delacruz | | DATE PREPARED: | 14th November 2003 | | DEVICE NAME: | | | Trade Name: | SAUFLON Flat Lens Case
SAUFLON 2003 Barrel Lens Case | | Common Name: | Contact Lens Case | | Classification: | CLASS II (21 CFR 886.5925) | #### DEVICE DESCRIPTION The SAUJFLON contact lens cases are moulded plastic, flat or barrel style cases with screw top leads, similar in design to currently marketed products. The barrel style include a lens basket used for holding the lens during storage. # INTENDED USE The SAUFLON Flat and Barrel Lens Case are intended for use for storage of soft, hard and rigid gas permeable contact lenses during chemical disinfection. Not to be used for heat disinfection. # PREDICATE DEVICE The Bausch and Lomb Lens Case was selected as the predicate device for the SAUFLON contact lens cases. # SUMMARY OF SAFETY AND EFFECTIVENESS Cytotoxicity, systemic toxicity and ocular irritation studies were performed to assess the safety and effectiveness of the SAUFLON Flat and Barrel Lens Case. Results of the testing show no evidence of cellular or systemic toxicity, or ocular irritation. # SUBSTANTIAL EQUIVALENCE: The SAUFLON contact lens cases are substantially equivalent in terms of indication for use, safety and effectiveness to the Bausch and Lomb Lens Case. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 FEB - 2 2004 KEA Plastics Ltd. c/o Dr. Ligia Delacruz Sauflon Pharmaceuticals Ltd. 49-53 York Street Twickenham, Middlesex TW1 3LP United Kindom Re: K033656 Trade/Device Name: SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (hydrophilic) contact lens care products Regulatory Class: Class II Product Code: LRX Dated: November 14, 2003 Received: November 21, 2003 Dear Dr. Delacruz: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 requrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {2}------------------------------------------------ Pagc 2 - Dr. Ligia Delacruz This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours. Ahalye Rosenthal A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a logo with a stylized eye-like symbol on the left and the text "SAURON PHARMACEU LIMITED" on the right. The text is stacked vertically, with "SAURON" on the top line, "PHARMACEU" on the second line, and "LIMITED" on the bottom line. The font appears to be sans-serif and the text is in black. 4-1 # SAUFLON CONTACT LENS CASES 510(k) # INDICATIONS FOR USE STATEMENT #### 510(k) Number (if known): K033686 Device Name: SAUFLON Flat Lens Case SAUFLON 2003 Barrel Lens Case Indications For Use: Prescription Use Storage of soft (hydrophilic), hard and rigid gas permeable (RGP) contact lenses during chemical disinfection only. Not to be used for heat disinfection. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Harvel W. Brown, Ph.D. Concur(Since Sion Sign Off)Office of Device Evaluation (ODE) Division of Ophthalmic Ear, Nose and Throat Devises 510(k) Number K033656 Prescription Use **__** OR Over-The-Counter X (Per 21 CFR 801.109) --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K033656](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LRX/K033656) **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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