(90 days)
Not Found
No
The summary describes a laser device for corneal surgery with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML training and testing.
No
The device is described as an ophthalmic surgical laser used for creating a corneal flap, which is an interventional procedure rather than a therapeutic one. It facilitates a surgical procedure but does not directly treat a disease or condition.
No
The device is described as an ophthalmic surgical laser used for creating corneal flaps, which is a surgical procedure, not a diagnostic test.
No
The device description explicitly states it is a "precision ophthalmic surgical laser" and describes its physical components and mechanism of action (creating micro-photodisruptions with focused ultrashort pulses delivered through a disposable applanation lens). This indicates it is a hardware device, not software-only.
Based on the provided information, the Pulsion™ FS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating a corneal flap during LASIK surgery or other corneal treatments. This is a surgical procedure performed directly on a living patient's tissue.
- Device Description: The device is a surgical laser that performs a cutting action on the cornea.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The Pulsion FS does not perform this function.
Therefore, the Pulsion FS is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Pulsion 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX, HNO
Device Description
The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION 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 Pulsion FS Laser has undergone testing and is in compliance with applicable safety standards. In addition, the Pulsion FS was found to perform equivalently to the predicate laser keratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the Pulsion FS Laser and the predicate device have similar safety, effectiveness or performance profiles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 2 7 2002
SECTION 11
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 summary 1. prepared;
- Applicant: a.
IntraLase Corp. 3 Morgan Irvine, CA 92618
- b. Contact Person:
J. Randy Alexander President and CEO
J. Randy Oliphley
November 26, 2001
Date Summary Prepared: C.
Name of device, including trade name and classification name: 2.
- Trade/Proprietary Name: Pulsion FS Laser a.
- b. Classification Name: Laser Keratome
- Identification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed:
| Company: | IntraLase Corp. |
|---|---|
| Device: | Pulsion FS Laser |
| 510(k): | K993153 |
| Date Cleared: | December 17, 1999 |
-
- 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):
1
The Pulsion FS Laser is a precision ophthalmic surgical laser designed for use in performing lamellar corneal resections. The cutting action of the PULSION 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.
ડ. Statement of intended use:
The Pulsion™ 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.
Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device.
The technological characteristics of the Pulsion FS Laser have already been cleared under K993153 for lamellar corneal resections. The design, materials, and characteristics of the laser keratome are the same irrespective of the indication for use.
Brief summary of nonclinical tests and results: 7.
The Pulsion FS Laser has undergone testing and is in compliance with applicable safety standards. In addition, the Pulsion FS was found to perform equivalently to the predicate laser keratome, with respect to the creation of corneal resections in extensive ex vivo and in vivo studies. Thus, the Pulsion FS Laser and the predicate device have similar safety, effectiveness or performance profiles.
2
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 a stylized image of an eagle with three lines forming its wing and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
FEB 2 7 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
IntraLase Corporation c/o Judy F. Gordon, D.V.M. ClinReg Consulting Services, Inc. 2 Delphinus Irvine, California 92612
Re: K013941 Trade/Device Name: Pulsion FS Laser Keratome Regulation Number: 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: November 26, 2001 Received: November 29, 2001
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, D.V.M.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse FDA finding of substantial equivalence of your device to a legally premaince hotification. The Pro intention 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 11 you desire specific and 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 OF IC For at 659. Additionally, for questions on the promotion and advertising of Compinatee at (301) 29 - 10th Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Oiner general mistmances, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
L. Mark A. Miller
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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Page 1 of 1
510(k) Number (if known): KO13941
Pulsion FS Laser Device Name:
Indications for Use:
The Pulsion™ FS is an ophthalmic surgical laser indicated for use in the creation of a The Fusion - TO is an opinating LASIK surgery or other treatment requiring initial lamellar resection of the cornea.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Perscription Use OR
Division Sign Off
Over-The-Counter Use (Optional Format 1-2-96)
ign-Off vision of General, Restorative and Neurological Devices
510(k) Number K013491
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