INTRALASE FS LASER

K031960 · Intra Lase Corp. · GEX · Sep 29, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031960
• Device Name: INTRALASE FS LASER
• Applicant: Intra Lase Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The INTRALASE® FS 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 FS Laser is an ophthalmic surgical laser for lamellar corneal resections. Device uses tightly focused ultrashort pulses to create precise individual microphotodisruptions of tissue. System includes a disposable applanation lens and utilizes low vacuum for eye fixation during the procedure. Operated by ophthalmic surgeons in a clinical setting. Output is a corneal flap created via laser photodisruption. Benefits include precision in corneal tissue resection for refractive surgery.

Clinical Evidence

Bench testing and nonclinical studies (ex vivo and in vivo) were conducted. The device demonstrated performance equivalent to the predicate laser in the creation of corneal resections. No clinical trial data provided.

Technological Characteristics

Ophthalmic surgical laser; utilizes ultrashort pulse laser technology for tissue photodisruption; includes disposable applanation lens; low vacuum eye fixation system. Complies with applicable safety standards.

Indications for Use

Indicated for patients undergoing LASIK surgery or other treatments 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

• Pulsion FS Laser (K013941)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS

THIS 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION IS BEING SUBMITTED IN ACCORDANCE WITH THE REQUIREMENTS OF SMDA 1990 AND 21 CFR 807.92.

- SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE 1. SUMMARY PREPARED
- a. Applicant:

IntraLase Corp. 3 Morgan Irvine, CA 92618

- b. Contact Person:
Judy F. Gordon, D.V.M.

Judy Harder/DD

- c. Date Summary Prepared:
June 20, 2003

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

- INTRALASE FS Laser a. Trade/Proprietary Name:
- b. Classification Name: Laser
- 3. IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:

| COMPANY: | IntraLase Corp. |
|---------------|-------------------|
| Device: | Pulsion FS Laser |
| 510(k): | K013941 |
| Date Cleared: | February 27, 2001 |

- 4. 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 FS Laser is a precision ophthalmic surqical laser designed for use in performing lamellar corneal resections. The cutting action of the

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# Section 11

# SUMMARY OF SAFETY AND EFFECTIVENESS

INTRALASE FS Laser is achieved through precise individual microphotodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.

#### 5. STATEMENT OF INTENDED USE:

The INTRALASE FS 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.

### 6. 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 FS Laser have already been cleared under K013941 for lamellar corneal resections. The slight changes made to the technological characteristics of the Laser do not alter the performance or indication of this device.

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

The INTRALASE FS Laser has undergone testing and is in compliance with applicable safety standards. In addition, the INTRALASE FS was found to perform equivalently to the predicate Laser, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness or performance profiles.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized human figure with three faces in profile, representing health, services, and people. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2003

IntraLase Corporation c/o Judy F. Gordon, D.V.M. Clinreg Consulting Services, Inc. 2 Delphinus Irvine, California 92612

Re: K031960 Trade/Device Name: INTRALASE™ FS Laser Keratome Regulation Number: 21 CFR 878.4810, 886.4370 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Keratome Regulatory Class: II Product Code: GEX, HNO Dated: June 20, 2003 Received: July 2, 2003

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.

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Page 2 - Judy F. Gordon, D.V.M.

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/dsma/dsmamain.html

Sincerely yours.

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ k 031 9 6 D ______________________________________________________________________________________________________________________________________

Device Name: INTRALASE FS Laser

Indications for Use:

The INTRALASE® FS is an ophthalmic surgical laser indicated for use in the creation of a corneal flap in patients undergoing LA'SIK surgery or other treatment requiring initial lamellar resection of the cornea.

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K031960

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
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OR

Over-The-Counter Use _ (Optional Format 1-2-96)