LOBOB UNIVERSAL CONTACT LENS CLEANER

K990044 · Lobob Laboratories, Inc. · LPN · Feb 11, 1999 · Ophthalmic

Device Facts

• Record ID: K990044
• Device Name: LOBOB UNIVERSAL CONTACT LENS CLEANER
• Applicant: Lobob Laboratories, Inc.
• Product Code: LPN · Ophthalmic
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5928
• Device Class: Class 2

Intended Use

To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.

Device Story

Lobob Universal Contact Lens Cleaner is a chemical solution for cleaning contact lenses. Originally indicated for rigid gas permeable (RGP) and hard (PMMA) lenses, this notification expands the indication to include soft (hydrophilic) contact lenses. The device is used by patients for routine lens maintenance. It functions as a cleaning agent to remove deposits and contaminants from the lens surface. Safety and effectiveness are supported by non-clinical testing (microbiology, toxicology, chemistry, manufacturing) and clinical data previously evaluated under PMA P950031.

Clinical Evidence

Clinical data obtained from a multi-center study involving 72 eyes using hydrophilic contact lenses followed for 3 months. Data was previously submitted and evaluated by the FDA in connection with PMA No. P950031.

Technological Characteristics

Chemical cleaning solution for contact lenses. Classified as a Class II soft (hydrophilic) contact lens care product (21 CFR 886.5928).

Indications for Use

Indicated for cleaning soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-silicone acrylate), and hard (PMMA) contact lenses.

Regulatory Classification

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

• Lobob Cleaner (P950031)

Submission Summary (Full Text)

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

2/11/99

510(k) Summary December 30, 1998

Submitted by:

Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street NW (#700) Washington, DC 20036 202-261-1000

On behalf of Lobob Laboratories, inc. 140 Atteberry Lane San Jose, CA 95131-1410

| Device Classification: | Class II -Soft (hydrophilic) contact lens care product (21 CFR 886.5928) |
|------------------------|--------------------------------------------------------------------------|
| Trade Name: | Lobob Universal Contact Lens Cleaner |
| Predicate Device: | Lobob Cleaner (P950031) |

Safety and Effectiveness Information:

The device is currently marketed as a cleaner for rigid gas permeable (RGP) and hard (PMMA) contact lenses. The current notification is for the added indication of cleaning soft (hydrophilic) contact lenses.

Lobob performed non-clinical and clinical testing on the device. The non-clinical testing supports the safety and effectiveness of the device from microbiology, toxicology, chemistry and manufacturing perspectives. Clinical data were obtained from a multi-center study involving a hydrophilic contact lens consisting of 72 eyes followed for 3 months. This data was submitted to and evaluated by FDA in connection with its approval of PMA No. P950031.

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

Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing right, with three curved lines above them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 1999

Lobob Laboratories, Inc. c/o Mr. Daniel J. Manelli FARKAS & MANELLI, P.L.L.C. 2000 M Street (#700) Washington, DC 20036

K990044 Re:

> Trade Name: Lobob Universal Contact Lens Cleaner Regulatory Class: II Product Code: 86 LPN Dated: January 21, 1999 Received: January 22, 1999

Dear Mr. Manelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is 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 Device 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 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 device 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.

{2}------------------------------------------------

Page 2 - Mr. Daniel Manelli

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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

revised 01/21/99

## Exhibit 3

l 1 Page of

K990044 510(k) Number (if known): j

Device Name:_Lobob Universal Contact Lens Cleaner

Indications For Use:

.

To clean soft (hydrophilic), rigid gas permeable (silicone acrylate, fluoro-sillcone acrylate) and hard (PMA) contact lenses.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

SM Haddle

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number _ 1 990044

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)