INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3

K060372 · Intra Lase Corp. · GEX · Aug 16, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060372
• Device Name: INTRALASE FS LASER, INTRALASE FS30 LASER, MODELS 1, 2, 3
• Applicant: Intra Lase Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use: In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; In lamellar keratoplasty and corneal harvesting; In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; In the creation of lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of penetrating cut/incision for penetrating keratoplasty.

Device Story

IntraLase FS Laser is an ophthalmic surgical laser for lamellar corneal resections and incisions. Device uses tightly focused ultrashort laser pulses to perform microphotodisruption of corneal tissue. System includes a disposable applanation lens; eye is fixated under low vacuum during procedure. Operated by physicians in clinical settings. Output is precise corneal tissue cutting/resection. Benefits include controlled, reproducible corneal incisions for refractive and therapeutic procedures.

Clinical Evidence

Bench testing only. The device was evaluated for safety and performance in creating corneal resections. Results demonstrated that the IntraLase FS Laser and its accessory patient interface perform equivalently to the predicate devices.

Technological Characteristics

Ophthalmic surgical laser; utilizes ultrashort pulses for microphotodisruption. Includes disposable applanation lens and vacuum fixation system. Operates as a standalone surgical unit. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring corneal surgery, including lamellar resection, corneal flap creation for LASIK, tunnel creation for corneal ring segments, lamellar keratoplasty, corneal harvesting, and penetrating keratoplasty.

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 600C Laser Keratome (K993153)
• IntraLase 600C Laser Keratome (K001211)
• IntraLase 600C Laser Keratome (K002890)
• Pulsion FS Laser Keratome (K013941)
• IntraLase FS Laser (K031960)
• IntraLase FS Laser (K041893)

Submission Summary (Full Text)

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K060372

## 510(k) Summary 5 5 510(k) Summary AUG 16 2006 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a). SUMBITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY 5.1 PREPARED a. Applicant: IntraLase Corp. 9701Jeronimo Road Irvine, CA 92618 [phone] Tel: Fax: [phone] b. Contact Person: Charline Gauthier, OD, PhD Executive Vice President & Chief Operating Officer IntraLase Corp. [phone] Tel: [phone] Fax:

- c. Date Summary Prepared February 7, 2006
5.2 NAME OF DEVICE, INCLUDING THE TRADE NAME AND CLASSIFICATION NAME:

- a. Trade/Proprietary Name: IntraLase FS Laser
- b. Common/Usual Name: Laser
- c. Classification Name: Keratome
- 79 GEX d. Classification Code(s): 86 HNO

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

| 510(k) # | Trade Name | Manufacturer |
|----------|-------------------------------|-----------------|
| K993153 | IntraLase 600C Laser Keratome | IntraLase Corp. |
| K001211 | IntraLase 600C Laser Keratome | IntraLase Corp. |
| K002890 | IntraLase 600C Laser Keratome | IntraLase Corp. |
| K013941 | Pulsion FS Laser Keratome | IntraLase Corp. |
| K031960 | IntraLase FS Laser | IntraLase Corp. |
| K041893 | IntraLase FS Laser | IntraLase Corp. |

## 5.4 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 surgical laser designed for use in performing lamellar corneal resections and incisions.

The cutting action of the 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.

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#### 5.5 STATEMENT OF INTENDED USE:

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:

- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
- . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
- In lamellar keratoplasty and corneal harvesting;
- . In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea;
- . In the creation of lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of penetrating cut/incision for penetrating keratoplasty.
- STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARE TO 5.6 THOSE OF THE PREDICATE OF LEGALLY MARKETED DEVICE.

The technological characteristics of the IntraLase FS Laser have already been cleared under K041893, K031960, K013941, K002890, K001211 and K993153 for lamellar corneal resections and incisions. The changes made to the labeling do not alter the performance or indication of this device.

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

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

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

JAN 2 5 2011

Intralase Corporation c/o Charlene Gauthier, OD, Ph.D. Executive Vice President and Chief Operating Officer 9701 San Jeronimo Rd. Irvine, CA 92618

Re: K060372

Trade/Device Name: INTRALASE® FS Laser Model 1, Model 2 and the INTRALASE® FS30 Laser Model 3

Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Regulatory Class: II Product Code: GEX. HNO Dated: April 4, 2006 Received: April 7, 2006

Dear Dr. Gauthier:

This letter corrects our substantially equivalent letter of August 16, 2006.

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 (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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Charlene Gauthier, OD, Ph.D.

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/Safety/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Sincerely yours,
Kesia Alexander

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

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# Indications for Use

510(k) Number (if known): K060372

Device Name(s): IntraLase FS Laser

Indications for Use:

The IntraLase® FS Laser is an ophthalmic surgical laser with the following indications for use:

- . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea;
- . In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments;
- In lamellar keratoplasty and corneal harvesting; �
- In the creation of a corneal flap in patients undergoing LASIK surgery or other o treatment requiring initial lamellar resection of the cornea:
- . In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Callaway

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K060372