SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,

K110452 · Unilens Corp., USA · LPL · Apr 20, 2011 · Ophthalmic

Device Facts

• Record ID: K110452
• Device Name: SOF-FORM II, UNILENS, UNISITE, SIMULVUE, AQUAFLEX, LL-38, BAYVUE AQUAFLEX MTO, UNILENS 38, UNISOFT, SIMULVUE 38 LLBI 2,
• Applicant: Unilens Corp., USA
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses

Device Story

Device represents a manufacturing process change for previously cleared soft (hydrophilic) daily wear contact lenses. The modification involves transitioning from standard sterilization validation to parametric release from moist heat sterilization. The lenses themselves remain unchanged in design, materials, and intended use. The device is used by patients for daily vision correction. The change affects the sterilization assurance process during manufacturing, ensuring the sterility of the lenses before distribution to eye care professionals and patients. No changes to clinical application or patient benefit are introduced by this process modification.

Clinical Evidence

No clinical data provided; bench testing only regarding sterilization process validation.

Technological Characteristics

Soft (hydrophilic) contact lenses; moist heat sterilization process; parametric release methodology.

Indications for Use

Indicated for daily wear of soft (hydrophilic) contact lenses for vision correction.

Regulatory Classification

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

• Sof-Form II (P820005)
• Unilens, Unisite, Simulvue (P850002)
• Aquaflex (P880101)
• LL-38 (P880102)
• BayVue, Aquaflex MTO (K940777)
• Unilens 38, Unisoft (K941836)
• Simulvue 38, LLBI 2 (K942372)
• Xtra, 4Vue (K942494)
• SoftSITE, EMA (K960926)
• Soft-55 DW (K961428)
• MV2 (K965012)
• LL Bifocal (K971647)
• MVt Toric Bifocal (K000529)
• C-VUE 55 (K002408)
• C-VUE 55 Toric Multifocal (K041608)
• Aquaflex 2 (K050743)
• C-VUE Advanced (K082393)
• C-VUE Advanced Definitive, C-VUE Advanced HydraVUE (K100456)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the agency's mission of providing health and human services to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Alan J. Frazer Director Quality Assurance UNILENS Corporation, USA 10431 72nd Street North Largo, FL 33777

APR 2 0 2511

Re: K110452 - Bundled Special 510 (k) for Parametric Release from Moist Heat Sterilization for Soft (hydrophilic) daily wear contact lenses cleared under P820005, P850002. P880101, P880102, K940777, K941836, K942372, K942494. K960926, K961428, K965012, K971647, K000529, K002408, K041608, K050743, K082393, K100456 Trade/Device Name: Soft Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: LPL Dated: March 23, 2011 Received: March 25, 2011

Dear Mr. Frazer:

We have reviewed your Special 510(k) premarket notification of intent to market the device referenced above which requests conversion to parametric release from moist heat sterilization of referenced hydrophilic contact lenses of 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 adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 may be subject to additional controls. Existing major regulations affecting your device can be

{1}------------------------------------------------

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 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/Safetv/ReportaProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours

Keoia Alexander

Image /page/1/Picture/10 description: The image shows a handwritten letter 'Ja' in cursive. The 'J' is elongated with a loop at the bottom and a curved top. The 'a' is connected to the 'J' and has a rounded shape. The writing is in black ink on a white background.

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}------------------------------------------------

Unilens Corp., USA Bundled Special 510(k)

Indications for Use

510(k) Number (if known): J K110452

Device Name: See Attached

Indications for Use:

For parametric release from Moist Heat Sterilization of Hydrophilic Contact Lenses

Over-The-Counter Prescription Use Use × -- AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Aura Postap

ision Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110452

Page 1 of 2

{3}------------------------------------------------

:

| Status | Trade Names | Approval<br>Number | Cleared<br>Date | Common<br>Name | Device<br>Class | Panel | Product<br>Code |
|--------|------------------------------------------------------------|--------------------|-----------------|--------------------------------------------------|-----------------|------------|-----------------|
| 510(k) | Sof-Form II | P820005 | 06/01/82 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Unilens, Unisite,<br>Simulvue | P850002 | 02/28/86 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Aquaflex | P880101 | 2/10/89 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | LL-38 | P880102 | 08/11/89 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | BayVue<br>Aquaflex MTO | K940777 | 4/12/1994 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Unilens 38, Unisoft | K941836 | 07/07/94 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Simulvue 38<br>LLBI 2 | K942372 | 07/07/94 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Xtra, 4Vue | K942494 | 09/08/94 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | SoftSITE, EMA | K960926 | 04/10/96 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Soft-55 DW | K961428 | 05/21/96 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | MV2 | K965012 | 03/11/97 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | LL Bifocal | K971647 | 07/15/97 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | MVt Toric Bifocal | K000529 | 02/16/00 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE 55 | K002408 | 10/17/00 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE 55 Toric<br>Multifocal | K041608 | 07/07/04 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | Aquaflex 2 | K050743 | 4/13/2005 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE Advanced | K082393 | 9/11/2008 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |
| 510(k) | C-VUE Advanced<br>Definitive<br>C-VUE Advanced<br>HydraVUE | K100456 | 10/28/2010 | Daily Wear Soft<br>(hydrophilic)<br>Contact Lens | II | Ophthalmic | LPL |

Page 2 of 2

: