(381 days)
Not Found
No
The description focuses on the laser's mechanical action and precision, with no mention of AI/ML terms, image processing, or data-driven decision making.
No
The device is used for surgical procedures on the cornea rather than for treating a disease or condition itself.
No
The device is an ophthalmic surgical laser used for cutting and resecting corneal tissue, not for diagnosing conditions.
No
The device description explicitly states it is a "precision ophthalmic surgical laser" and describes its physical cutting action using "ultrashort pulses delivered through a disposable applanation lens," indicating it is a hardware device.
Based on the provided information, the INTRALASE® FS Laser is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- INTRALASE FS Laser Function: The description clearly states that the INTRALASE FS Laser is an "ophthalmic surgical laser" used for "performing lamellar and full thickness or penetrating corneal resections." This is a surgical procedure performed directly on the patient's eye (in vivo), not an examination of a specimen outside the body.
- Intended Use: The indications for use all describe surgical procedures on the cornea.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens (blood, tissue, etc.) with this device.
Therefore, the INTRALASE FS Laser is a surgical device, not an IVD.
N/A
Intended Use / 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 intial lamellar ● resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar o resection of the cornea to create tunnels for placement of the 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 a lamellar cut/resection of the cornea for lamellar . keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty
Product codes
GEX
Device Description
The INTRALASE FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The INTRALASE FS Laser has undergone testing in accordance with applicable safety standards. In addition, the INTRALASE FS was found to perform equivalently to the predicate devices with respect to the creation of partial or full thickness corneal resections 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. Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness and performance profiles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
JUL 29 2005 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.
1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON, AND DATE SUMMARY PREPARED
| a. Applicant: | IntraLase Corp. |
|---|---|
| 3 Morgan | |
| Irvine, CA 92618 |
- b. Contact Person: Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92603
- c. Date Summary Prepared: May 9, 2005
NAME OF DEVICE, INCLUDING TRADE NAME AND CLASSIFICATION NAME: 2.
- Trade/Proprietary Name: INTRALASE FS Laser a.
- b. Classification Name: Laser
3. IDENTIFICATION OF THE PREDICATE DEVICE OR LEGALLY MARKETED DEVICE OR DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS BEING CLAIMED:
| 510(k) | Applicant | Name of Device | Date Cleared |
|---|---|---|---|
| K981063 | Laser Center | ||
| Development | |||
| Corporation | Automated Corneal | ||
| Trephine | June 23, 1998 | ||
| K013151 | BKG Ophthalmics | ||
| USA, Inc. | ASMOTOM Automated | ||
| Corneal Trephine | December 14, | ||
| 2001 | |||
| K002890 | IntraLase Corporation | Femtosecond Laser | |
| Keratome | August 9, 2001 |
1
-
- 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 and full thickness or penetrating corneal resections. The cutting action of the INTRALASE FS Laser is achieved through precise individual micro-photodisruptions of tissue, created by tightly focused ultrashort pulses which are delivered through a disposable applanation lens while fixating the eye under very low vacuum.
- 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):
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 a lamellar cut/resection of the cornea for lamellar keratoplasty and in the creation of a penetrating cut/incision for penetrating keratoplasty.
These additional indications for use are identical to those of the predicate devices.
STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE.
The technological characteristics of the INTRALASE FS Laser have already been cleared under K002890 for corneal harvesting. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use.
2
7. BRIEF SUMMARY OF NONCLINICAL TESTS AND RESULTS:
The INTRALASE FS Laser has undergone testing in accordance with applicable safety standards. In addition, the INTRALASE FS was found to perform equivalently to the predicate devices with respect to the creation of partial or full thickness corneal resections 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. Thus, the INTRALASE FS Laser and the predicate device have similar safety, effectiveness and performance profiles.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Intralase Corporation c/o Judy F. Gordon, D.V.M. Regulatory Consultant to IntraLase ClingReg Consulting Services, Inc. 2 Delphinus Irvine, CA 92603
JAN 2 5 2011
Re: K041893
Trade/Device Name: INTRALASE FS Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology Regulatory Class: II Product Code: GEX Dated: July 6, 2005 Received: July 7, 2005
Dear Dr. Gordon:
This letter corrects our substantially equivalent letter of July 29, 2005.
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
4
Page 2 - Judy F. Gordon, D.V.M.
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/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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
5
Indications for Use
510(k) Number (if known): K041893
INTRALASE FS Laser Device Name(s):
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 intial lamellar ● resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar o resection of the cornea to create tunnels for placement of the 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 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)
S. Calloway
(Division Sign-Off)
Page 1 of __ 1 ___
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
510(k) Number K041893