INTRALASE FUSION LASER

K063682 · Intra Lase Corp. · GEX · Feb 9, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063682
• Device Name: INTRALASE FUSION LASER
• Applicant: Intra Lase Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 9, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Story

IntraLase Fusion Laser is a precision ophthalmic surgical laser for lamellar corneal resections and incisions. Device utilizes ultrashort laser pulses to create precise micro-photodisruptions of corneal tissue. System includes a disposable applanation lens assembly and operates under low vacuum to fixate the eye. Used by ophthalmic surgeons in clinical settings to create corneal flaps during LASIK or similar procedures. Surgeon controls laser delivery to achieve precise tissue cutting, facilitating subsequent surgical steps. Benefits include high-precision tissue resection compared to mechanical methods.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with applicable safety standards and compared to the predicate device. Results demonstrated equivalent performance in the creation of corneal resections.

Technological Characteristics

Ophthalmic surgical laser; utilizes ultrashort pulse micro-photodisruption; includes disposable applanation lens assembly; low vacuum eye fixation; Class II device; 21 CFR 878.4810.

Indications for Use

Indicated for creation of corneal flaps in patients undergoing LASIK surgery or other procedures requiring initial lamellar resection of the cornea.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• IntraLase FS Laser (K060372)

Submission Summary (Full Text)

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

#### 9 2007 FER

### 510(K) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

## SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED:

- IntraLase Corp. Applicant: વ. 9701 Jeronimo Road Irvine, CA 92618 Tel: [phone] Fax: [phone] Betty Johnson Contact Person: ﻓ
...

- IntraLase Corp. 9701 Jeronimo Road Irvine, CA 92618 Tel: [phone] Fax: [phone] [e-mail]
- c. Date of Summary Preparation February 1, 2007

#### NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME:

| Trade/Proprietary Name: | IntraLase Fusion Laser |
|-------------------------|------------------------|
| Common/Usual Name: | Laser |
| Classification Name: | Keratome |
| Classification Code(s): | 79 GEX, 86 HNO |

### IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

| 510(k) # | Trade Name | Manufacturer |
|----------|--------------------|-----------------|
| K060372 | IntraLase FS Laser | IntraLase Corp. |

### A DESCRIPTION OF THE DEVICE THAT IS THE SUBJECT OF THE 510(K), INCLUDING EXPLANATION OF HOW THE DEVICE FUNCTIONS, BASIC SCIENTIFIC CONCEPTS, SIGNIFICANT PHYSICAL AND PERFORMANCE CHARACTERISTICS (DESIGN, MATERIAL, PHYSICAL PROPERTIES):

The IntraLase Fusion Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections and incisions. The cutting action of the IntraLase Fusion Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused

(02/01/2007) K063682 of ನ್ನೆ ಮತ್ತು

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

ultrashort pulses which are delivered through a disposable applanation lens assembly while fixating the eye under low vacuum.

### STATEMENT OF INTENDED USE:

The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

### STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE:

The technological characteristics of the IntraLase Fusion Laser have are substantially equivalent to those cleared under K060372 for lamellar corneal resections and incisions.

#### BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:

The IntraLase Fusion Laser has undergone testing and is in compliance with applicable safety standards. The IntraLase Fusion Laser and the accessory IntraLase Fusion Patient Interface were found to perform equivalently to the predicate laser and patient interface for the creation of corneal resections. Thus, the IntraLase Fusion Laser and the predicate device have similar safety, effectiveness and performance profiles.

#### Page 2 of 2

(02/01/2007) K063682 S OF 6

1-11

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

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IntraLase Corp. c/o Judy F. Gordon, DVM ClinReg Consulting Services, Inc. 733 Bolsana Dr. Laguna Beach, CA 92651

9 2007 FEB

Re: K063682

Trade/Device Name: IntraLase® Fusion™ Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Codes: GEX, HNO Dated: December 8, 2006 Received: December 11, 2006

Dear Dr. Gordon:

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 adulteration.

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 requirements, 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.

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

Page 2 - Judy F. Gordon, DVM

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Egelman Si MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

IntraLase Corp.

# CDRH INDICATIONS FOR USE

510(k) Number (if known): K063682

. ..

IntraLase Fusion™ Laser Device Name(s):

Indications for Use:

The IntraLase Fusion™ Laser is an ophthalmic surgical laser indicated for use in the creation of corneal flaps in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Prescription Use _ X (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)

oncurrence of CDRH, Office of Device Evaluation (ODE)

Muska R. Burke Nicholas
(Division Sign Off)

sion of Ophthalmic Ear Nose and Throat Devi

510(k) Number

Page 1 of __ 1__

3 OF 5 (02/01/2007) K063682